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Report of the |
Surgeon General's Workshop on Osteoporosis and Bone Health |
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December 12-13, 2002, Washington, D.C. |
This web page provides the proceedings of the Surgeon General's Workshop
on Osteoporosis and Bone Health held on December 12th and 13th of 2002 in Washington,
DC. The workshop was designed to give scientific experts, health care professionals,
public health officials, representatives from foundations and advocacy groups,
and individuals living with osteoporosis and other related bone diseases the
opportunity to identify the most important priorities for the upcoming Surgeon
General's Report on Osteoporosis and Bone Health.
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THE BURDEN OF DISEASE: BONE HEALTH, OSTEOPOROSIS, AND RELATED BONE DISEASES
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PROMISING PUBLIC HEALTH PREVENTION STRATEGIES FOR INDIVIDUALS AND FAMILIES IN COMMUNITIES
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OPPORTUNITIES IN BEHAVIORAL AND SOCIAL SCIENCES RESEARCH FOR ADDRESSING OSTEOPOROSIS
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BREAK-OUT GROUP RECOMMENDATIONS FOR THE SURGEON GENERAL'S REPORT
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This nation faces a serious yet largely unknown health problem. More than one in 10 Americans either has or is at risk of developing a bone disease. Yet the vast majority of these individuals remain undiagnosed and untreated. As a result, bone disease exacts a huge toll on the nation. Osteoporosis, by far the most common bone disease, is responsible for approximately 1.5 million fractures each year. As many as 300,000 individuals who suffer an osteoporosis-related fracture die as a result of complications from the injury.
Concerns about the large toll that bone diseases are inflicting on the nation has led the Surgeon General to launch a major campaign aimed at improving bone health. A core component of this campaign was the Surgeon General's Workshop on Osteoporosis and Bone Health, held December 12th and 13th of 2002 in Washington, DC. This meeting served as an opportunity for key stakeholders to provide input on the most important priorities for The Surgeon General's Report on Osteoporosis and Bone Health, to be released in 2004.
The workshop was preceded by an invitation made through the Surgeon General's Website to the public to share ideas about the priorities for the workshop and the upcoming Surgeon General's Report. These comments emphasized the importance of public education, education and training of health professionals, better access to services, better information (especially for those at risk), and more research and guidelines for prevention, screening, diagnosis, and treatment. (Click here to see a summary of public comments.)
The workshop was designed with these public comments in mind. The goal was to identify the most important issues in bone health from a variety of perspectives, including those of the public, providers, payers, the research community, and industry. It was structured to compile the best evidence from the best minds, with the information being used as a foundation for the 2004 Surgeon General's Report. To that end, the workshop included presentations from experts in bone research and treatment, health promotion and disease prevention, Federal officials, and advocacy organizations. It also provided an opportunity to hear from people who live with bone disease every day.
Most important, the workshop included time for attendees to break into groups to discuss the challenges and opportunities for action to improve bone health within six discrete areas: 1) public awareness and marketing, 2) health care professional knowledge and attitudes, 3) research on health promotion, 4) early prevention through healthy lifestyles and awareness, 5) access to diagnosis, screening, and treatment, and 6) state and local strategies. The results from these small group discussions will help to set priorities for the writing of The Surgeon General's Report on Osteoporosis and Bone Health.
RADM Kenneth P. Moritsugu, M.D., M.P.H.
U.S. Deputy Surgeon General
Dr. Moritsugu conveyed regrets on behalf of the Surgeon General, VADM Richard Carmona, M.D., M.P.H., F.A.C.S., who was unable to be at the meeting due to an emergency. Dr. Moritsugu read a statement from Dr. Carmona emphasizing the importance of addressing bone disease, a silent killer that robs too many Americans, especially women, of health throughout their lives. While affecting more than one in 10 Americans, bone diseases such as osteoporosis, Osteogenesis Imperfecta (OI), and Paget's Disease are largely unfamiliar to the majority of Americans. Physicians, who typically know of these diseases, are often unaware of appropriate management and treatment for them. And like many chronic diseases, osteoporosis—the most prevalent bone disease—is largely preventable. Dr. Carmona's top priority as Surgeon General is to prevent debilitation and premature mortality from all causes, including bone disease and injury, in Americans.
Dr. Moritsugu emphasized the importance of taking a public health approach to bone disease. Bone loss usually develops slowly over a lifetime. Only recently has the extent to which it affects Americans (especially women) become clear. An estimated 34 million Americans have reduced bone mass and 10 million have osteoporosis. While 80% of those with osteoporosis are women, men also suffer from bone disease. In fact, half of women and one quarter of men over the age of 50 will have an osteoporosis-related fracture sometime during their lifetime. The disease affects all races and ethnic groups; Asian women, non-Hispanic white women, Hispanic women, and African-American women over the age of 50 are all at risk for osteoporosis, although to varying degrees. Yet despite these statistics, the disease remains little understood by the general public (including those at the greatest risk) and the medical community. The vast majority of women and men with the disease remain undiagnosed and untreated today. As a result, osteoporosis imposes a huge toll on its victims. Roughly 1.5 million individuals will suffer an osteoporosis-related fracture this year. Up to 20% of those suffering hip fractures will die from injury-related complications within a year.
The good news is that the risk factors for osteoporosis are well understood and in many cases controllable. Risk factors include improper diet, lack of exercise, smoking, excessive use of alcohol, being female, being thin or having a small frame, advanced age, a family history of the disease, and a history of anorexia nervosa or low calcium intake. Dr. Moritsugu emphasized the importance of taking all these risk factors into account in developing a prevention strategy, and he highlighted the need for Americans to stop smoking and drinking, to exercise and eat well, and to get the appropriate vitamins and minerals, including calcium, into their diets. These changes will help reduce the incidence of many other diseases as well. This workshop and the upcoming Surgeon General's Report may be seen as evidence of the high priority the Surgeon General is giving to the promotion of bone health and prevention of bone disease.
Eve Slater, M.D.
Former Assistant Secretary for Health
Dr. Slater conveyed the gratitude of Tommy Thompson, Secretary of the Department of Health and Human Services (DHHS), to workshop attendees. Dr. Slater noted that Secretary Thompson believes that osteoporosis and bone health are both long overdue for this level of attention (i.e., a Surgeon General's Report). Since 1964, the Surgeon General has been communicating directly with the public on important health issues. The first report on smoking had a dramatic impact on public perceptions and on smoking rates. A Gallup survey in 1958 found that only 44% of Americans believed that smoking caused cancer. By 1968 (four years after the release of the Surgeon General's Report on smoking), that figure had increased to 78%. (Part of the increase may have been driven by the 1965 Congressional mandate that cigarette packages contain a health warning; this legislation was also a reaction to the report.) More important, perhaps, smoking rates have fallen by roughly 50% since the report was issued.
Other reports by the Surgeon General have also had a major impact. The 1986 report on HIV/AIDS met with great acclaim and instant controversy. It materially affected both the public's and the medical profession's conceptions of the disease, literally changing the mindset of the nation. In closing, Dr. Slater called on workshop attendees to use their collective memories, superb reasoning skills, and imagination in proposing strategies to improve bone health.
Joan A. McGowan, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Dr. McGowan will serve as senior scientific editor for the Surgeon General's Report. She highlighted several of the key challenges facing the bone field, including finding ways to take actions inside and outside of health care settings to promote prevention, screening, and treatment. She called on the field to look outside of bone health for promising models and best practices. She urged workshop attendees to keep in mind the myriad forms of bone disease in their efforts. While osteoporosis is naturally the primary focus (due to its prevalence and the existence of substantial knowledge about prevention and treatment), other, rare bone diseases can also benefit from early diagnosis and intervention. Dr. McGowan noted that the U.S. is now a formal part of the Decade of the Bone and Joint, an international effort to raise awareness among the public and the medical community about all musculoskeletal diseases. The Surgeon General's Report will play an important role in this international effort.
Lawrence G. Raisz, M.D.
University of Connecticut Health Center
Dr. Raisz will serve as a scientific editor for the upcoming report. Noting that he and his peers (affectionately known as "bone heads") tend to focus on how to diagnose and treat bone diseases, he is especially enthusiastic and excited about the focus on prevention and public health that will be a centerpiece of the Surgeon General’s Report. Dr. Raisz believes that the goal of the report should be to change the mindset about the disease. But because the problems are big, complex, and far-reaching, a simple "here’s-what-to-do" prescription will not work. Getting the message out, in fact, will be a challenge. But the workshop is an excellent start, as it will produce immediate action plans. The report will build on the workshop by collating and verifying meaningful, effective strategies that can be implemented to prevent and treat bone disease throughout an individual’s life (from "cradle to fracture"). The ultimate goal from this effort should be to enact a vast array of changes that collectively serve to make bone disease a thing of the past. Achieving this goal will require the collective hard work of a variety of different stakeholders.
The first panel focused on the basics of bone biology as well as the toll that bone disease exacts on society and individuals, in terms of the incidence, prevalence, and costs of the disease. The panel also included personal testimonials from two individuals with first-hand experience of the burdens imposed by bone disease. The panel was chaired by Vivian Pinn, M.D., of the National Institutes of Health's Office of Research on Women's Health.
B. Lawrence Riggs, M.D.
Mayo Clinic and Foundation
Dr. Riggs reviewed the challenges and opportunities in the field of bone health. He began by describing the complex and dynamic functions of bone, which include promoting locomotion, protecting internal organs, remodeling in response to mechanical strain, remodeling to repair microdamage, remodeling to support calcium homeostasis, and producing hematologic and immune cells in the bone marrow.
The key to healthy bones is maintaining optimal levels of “bone mass.” Bone mass varies over time in individuals, depending upon how much new bone is being formed and how much is being lost (also known as resorption). Bone turnover is a measure of the net rate of formation and resorption in an individual. Both men and women tend to have higher rates of formation than resorption during their childhood years (particularly around puberty). During adulthood, rates of resorption generally equal formation, leading to relatively stable levels of bone mass. After menopause, women experience periods of net bone loss, as demonstrated in Figure 1 below. Men also lose bone after age 50, although on average only half as much as women. One reason for this is that estrogen is as important to bone health for men as it is for women, but, unlike post-menopausal women, elderly men tend not to suffer a rapid decline in estrogen levels. That said, there is evidence that elderly men may face a period of rapid bone loss once they fall below a threshold level of estrogen. Roughly half of men over the age of 75 have fallen below this threshold level.
Figure 1. Bone Turnover at the Tissue Level: Patterns in Women
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Source: Lawrence Riggs, Mayo Clinic
Bone mass is determined by a variety of endogenous factors such as genetics, age, and sex, as well as exogenous factors including nutritional status (e.g., levels of calcium, protein, and Vitamin D), activity levels, environmental risk factors (e.g., smoking, alcohol consumption), presence of certain diseases, and use of certain drugs (e.g., corticosteroids).
The primary bone disease affecting Americans is age-related osteoporosis. Individuals with this disease are more prone to fractures. Fracture risk is increased by the following: low bone density, previous fractures, microstructural damage, high bone turnover, and trauma (e.g., due to a fall). Fortunately, osteoporosis is a preventable and treatable public health problem. Enormous advances have been made in understanding its pathophysiology. Effective drug therapy can help to prevent and treat the disease. The challenge is to implement education and awareness programs oriented toward the public and health care professionals. If these efforts are made, there is a very real opportunity to bring osteoporosis under control within the near future.
Unfortunately, the prospects for preventing other related bone disorders are less bright. These diseases include Paget's Disease, which affects approximately 3% of Americans over the age of 40. This localized bone disease (caused by excessive bone resorption from abnormal osteoclasts (OC) with replacement by abnormal bone) can be painful and deforming. While genetics plays a role in the disease, there is also strong evidence that the measles virus contributes as well. Fortunately, drugs known as bisphosphonates offer the potential for excellent control of (or perhaps even a “cure” for) the disease in many patients.
A rarer but more debilitating genetic bone disease is Osteogenesis Imperfecta or OI. At least six genotypes of the disease have been found, which is characterized by increased bone fragility, ranging from mild to severe. Severe fragility can result in multiple fractures, deformity, and even death before or shortly after birth. Bisphosphonate therapy has recently been shown to reduce fractures in severe cases (even among small children). Gene therapy may offer some hope for the future.
L. Joseph Melton, III, M.D.
Mayo Clinic and Foundation
Dr. Melton reviewed the burden caused by the most common of bone diseases, osteoporosis. He began by noting that most people have relatively stable bone mass in mid-life, but lose bone as they get older (particularly women during and after menopause).
Projecting data from the National Health and Nutrition Examination Survey (NHANES), it is estimated that more than 10 million Americans over the age of 50 have osteoporosis, including 7.8 million women and 2.3 million men. Another 33.6 million over the age of 50 have low bone mass and thus are at risk for osteoporosis. Looking to the future, the aging of the population will drive rapid increases in these figures, as demonstrated in Table 1.
Table 1. Projected Prevalence of Osteoporosis and/or Low
Bone Mass of the Hip in U.S. Women and Men50 Years Old
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Source: America's Bone Health, National Osteoporosis Foundation, 2002.
The big problem with osteoporosis is the risk of a fracture, which grows exponentially as individuals age and bone mass weakens (see Figure 2 below). Dr. Melton believes that virtually all fractures in the elderly are due at least in part to low bone density. In fact, the lifetime risk of a hip, spine, or forearm fracture is nearly 40% among 50-year-old Caucasian women and more than 13% among Caucasian men. Given improving life expectancy and the increasing incidence of hip fractures, data from Sweden suggest that these risks may rise dramatically in the years ahead (see Table 2).
Figure 2. Age-Related Fractures
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Source: Cooper C; Melton LJ. Epidemiology of osteoporosis. TEM 1992;
3:224-229, with permission from Elsevier.Table 2. Lifetime Risk of Hip Fracture at Age 50 Years
[d]
Source: L. Joseph Melton, using data from a paper by Oden A; Dawson A;
Dere W; Johnell O; Jonnson B; Kanis JA. Lifetime risk of hip fractures is
underestimated. Osteoporosis Int 1998; 8:599-603, Table 3.
Not surprisingly, individuals who suffer fractures frequently lose the ability to perform everyday functions. Dr. Melton shared data showing that roughly one in 10 individuals who suffer a hip fracture becomes functionally dependent as a result of the fracture, while nearly twice that many end up in a nursing home. In fact, 140,000 nursing home admissions each year are the direct result of a hip fracture. More than 4% of spine fracture victims become functionally dependent, while 1.9% end up in a nursing home. A study of women in Rancho Bernardo, California, found that those women suffering hip fractures are more than 11 times more likely to need help cooking meals, 4.6 times more likely to need help shopping, 2.8 times more likely to need help with heavy housework, and 1.6 times more likely to need help putting on their socks than are their peers who have not suffered a hip fracture. (See Table 3 for additional data on the disabling nature of spine and wrist fractures.)
Table 3. Risk of Functional Impairment with Minimal Trauma
Fractures Among Women in Rancho Bernardo, CA
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Source: Greendale GA; Barrett-Connor E; Ingles S; Haile R. Late physical
and functional effects of osteoporotic fracture in women: the Rancho
Bernardo study. JAGS 1995 Sept; 43(9):955-961.
And while disability and loss of functional status may be the most common impact from fractures, a small but significant portion of women and men die as a direct result of a fracture. In fact, hip fractures alone result in a 12% to 20% decline in expected survival. Survival rates for men are much worse than for women, especially among very old men.
Dr. Melton concluded his comments by noting that osteoporosis is as prevalent as the most common chronic diseases. The risk of disabling and life-threatening fractures that are related to osteoporosis is high. Looking ahead, the incidence of fractures will increase dramatically with the aging of the population. As a result, greater investments in preventive strategies are urgently needed.
Anna Tosteson, Sc.D.
Center for the Evaluative Clinical Sciences at Dartmouth Medical School
Dr. Tosteson reviewed estimates of the economic burden imposed by bone disease. Summarizing the results of several cost-of-illness studies, she noted that the direct costs of osteoporosis in 2001 are between $11.6 and $17.1 billion. Data from one study suggest that the vast majority (76%) of these costs are estimated to be the result of white women who have the disease, with another 18% the result of white men. Only 6% of the costs are attributable to nonwhite men and women with osteoporosis. Hip fractures account for 63% of the costs, with other fractures accounting for 37%. Just under two-thirds (63%) of these costs are due to hospital services, with another 28% the result of nursing home care. The government pays for the lion's share of the health care costs of osteoporosis in women over the age of 45, with Medicare paying nearly half (48%) and Medicaid covering nearly a quarter (24%) of the expenses.
Osteoporosis not only imposes direct costs on society, but indirect costs as well, including the costs of morbidity and premature mortality. Moreover, as older Americans remain in the workforce, osteoporosis results in loss of productivity.
While cost-of-illness studies have helped to establish osteoporosis as a public health priority and have identified the high direct costs of the disease, they have not adequately addressed prevention, considered the economic consequences of the disease over a lifetime, or adequately measured indirect costs. To get at some of these issues, Dr. Tosteson shared the results of several cost-effectiveness studies that were designed to assess the relative value of alternative interventions. The rationale behind these types of studies is to ensure that expenditures provide benefits that are worth the additional costs. This type of analysis is especially important in an era of limited financial resources. Most cost-effectiveness studies have focused on postmenopausal women, considering single-age cohorts. These studies have helped to determine the appropriate age of intervention and the expected amount of time before the benefits of treatment are to be realized. This latter calculation can have a significant impact on the perceived benefits for different stakeholders. For example, a private insurer that covers post-menopausal women until they reach the age of 65 (and become eligible for Medicare) will typically have a 10-year time horizon. For these insurers, widespread bone density testing and medication may not be cost-effective, since relatively few fractures are likely to occur during the 10 years of coverage. On the other hand, targeted programs aimed at high-risk individuals are likely to be cost-effective for these insurers. A government insurer such as Medicare, however, may view widespread screening and interventions among postmenopausal women as highly cost-effective, as these early interventions may prevent fractures (and the associated costs of hospitalization and nursing home care) in later years.
Dr. Tosteson concluded by noting that bone diseases result in large economic costs to society, costs which are increasing. Fortunately, opportunities for cost-effective prevention and treatment are also increasing; these approaches must be identified and implemented. Successful implementation requires consideration of the impact of alternative strategies on the health of the entire population.
The panel included presentations by two individuals whose stories demonstrate the personal burden suffered by those who live with osteoporosis and other bone diseases on a daily basis.
Linda Johnson
Linda Johnson, who suffers from osteoporosis, has become a national spokesperson on the disease. Her story is a classic example of the terrible consequences that occur when the medical profession fails to recognize the possibility of osteoporosis in a younger woman.
She began suffering bone fractures while still in her thirties. One of her most vivid memories from this time is when her young sons and daughters would remind each other “not to touch mommy because she will break.” Even as pain levels increased and her quality of life suffered, her doctor blamed her problems on clumsiness. After she turned 40, her internist attributed her problems to being a natural consequence of “getting old.” Finally, after breaking her ankle at the age of 43, an orthopedist diagnosed osteoporosis. At this point she had lost bone mass and was shorter than earlier in life, probably due to spine fractures. The doctor told her there was no treatment available for osteoporosis. He advised her to take calcium supplements and to exercise, although he provided no guidance on what types of exercises would be helpful and safe. While she had a long list of “don'ts” with respect to her life, she did find that exercise made her feel better. Yet she remained paralyzed with fear, particularly after her physician gave her the following advice: “above all else, don't fall.”
Today at age 55, Ms. Johnson has finally turned the corner on the disease. Thanks to medical treatment, calcium supplements, and exercise, her bone mass has improved. She is no longer considered to have osteoporosis, but rather is classified as osteopenic (i.e., she has low bone mass). She has even regained some height.
As she reflects on her experience, Ms. Johnson is concerned about the millions of other individuals who have osteoporosis or who are at risk of getting it. She reminded the audience that osteoporosis is not necessarily your “grandmother's disease.” It can affect younger individuals, and therefore it is critical for the public and medical professionals to learn more about the disease. Failure to follow this strategy may mean that the disease of osteoporosis “breaks the bank” with respect to health care costs. As Ms. Johnson noted, “people with osteoporosis do not just die; they slowly break apart.”
they slowly break apart.” — Linda Johnson
Jean Mandeville
Jean Mandeville offers the perspective of a parent who has two children with bone disease, a daughter (now 25 years old) with osteoporosis and a son (now 28 years old) with severe OI. Her son suffered nearly a dozen bone fractures at birth. Her instructions from the physicians upon taking him home were to “be careful.” When her son was two months old, she heard the horrible sound of his arm breaking as she turned him over in his crib. To date, he has suffered 140 fractures, some caused by acts as simple as sneezing or being startled. Fractures, however, are not the only health problems he faces. Like many OI sufferers, he also must endure problems such as scoliosis, broken teeth, hernias, kidney stones, and hearing loss. He presently requires full-time oxygen. Only three feet tall, he has never slept through the night.
Yet like many OI patients, Ms. Mandeville's son is highly intelligent and engaging, a true joy to be around. He spoke in complete sentences by the age of one and was reading at the age of two. He showed an interest in politics by age five, querying his mother on whom she was going to vote for in the presidential election, and why. His tremendous intellectual abilities and engaging personality are as much or more a part of him as are his disabilities. Like many OI sufferers, his personality and story make him an excellent spokesperson for the disease. But like all OI sufferers, he would like help as well. With limited treatment options and no possibility for prevention, OI remains a terrible disease that needs to be further researched. To that end, Ms. Mandeville called for the following: better tools to assess the strength of bones in OI patients and to evaluate the relative merits of various therapies for OI; creation of a national center for OI that could serve as a clearinghouse for information on the disease; and increased spending on OI research to reduce the burden of the disease.
The second panel, chaired by David Atkins, M.D., M.P.H., of the Agency for Healthcare Research and Quality (AHRQ), focused on the latest evidence related to diagnosis, treatment, and secondary prevention (i.e., preventing falls and fractures) in individuals diagnosed with osteoporosis and related bone diseases.
Dennis Black, Ph.D.
University of California, San Francisco
Dr. Black reviewed one of the key issues in diagnosis of osteoporosis—use of bone mineral density (BMD) measurements both as a diagnostic tool and as a risk factor for fracture. He began by describing the technology for measuring BMD. Known as a dual energy x-ray absorptiometry or DXA, this test measures BMD at multiple skeletal sites, including the spine and proximal femur. An office-based procedure that involves minimal exposure to radiation, the DXA test costs roughly $125 and is in most instances covered by Medicare.
As illustrated in Figure 3, hip BMD is a good predictor of the risk of fractures in Caucasian women over the age of 65. Those individuals in the highest-quartile with respect to hip BMD (i.e., those with the highest levels of bone mass) are at the least risk of a fracture, while those with low hip BMD have significantly higher risk of fracture. In fact, hip BMD is a better predictor of hip fracture than are standard screening tests for other diseases. For example, BMD levels do a better job of predicting the risk of hip fracture than do cholesterol levels at predicting heart disease. That said, measurement of BMD at other parts of the body (e.g., a wrist, a heel) tends to be less predictive of fracture risk, especially hip fractures. While these peripheral tests have some advantages (they are less costly, emit less radiation, and are portable), they also tend to be less reliable as tools for predicting fracture. Because of these problems, the consensus in the field is that central densitometry should be used for a definitive diagnosis whenever possible.
Figure 3. Femoral Neck (Hip) BMD Predicts Various Types of Fractures
[d]
Sources: Black DM, Cummings SR, Genant HK et al. Axial and appendicular bone
density predict fractures in older women. J Bone Mineral Res 1992; 7(6):633-638.Cummings SR; Black DM; Nevitt MC; Browner W; Cauley J; Ensrud K, et al. Bone
density at various sites for prediction of hip fractures. Lancet 1993 Jan; 341(8837):72-5.
Dr. Black noted the development of a classification system that translates BMD scores into diagnosis. This system relates an individual's bone density to that of a normal population of individuals. This comparison uses a “t-score” to indicate the number of standard deviations that an individual falls below or above a standardized normal BMD (0.89 grams per square centimeter, a level that occurs in most individuals around puberty). The World Health Organization (WHO) created three diagnostic categories based on t-scores. Individuals within one standard deviation of peak BMD are considered normal, those one to 2.5 standard deviations below normal are deemed to be osteopenic or have low bone mass, while those 2.5 or more standard deviations below peak BMD are considered to have osteoporosis. The National Osteoporosis Foundation (NOF) recommends that physicians seriously consider prophylactic therapy for individuals with a t-score that is two or more standard deviations below peak BMD. Individuals with known risk factors should be considered for such treatment if t-scores fall 1.5 or more standard deviations below peak BMD.
BMD, however, is not the only risk factor that is predictive of the potential for fractures. While each one-standard-deviation drop in BMD (equivalent to a 10% to 13% decrease) increases the risk of hip fracture by 2.4 times, other risk factors are also strongly predictive of hip fractures, including age (every five-year increase raises the risk of hip fracture by 50%), weight (every 20% decline in weight after the age of 25 increases the risk of hip fracture by 70%), a history of fracture since the age of 50 (which raises the risk of a hip fracture by 50%), having an existing spine fracture, or having a mother who has fractured her hip. (These latter two factors each double the risk of hip fracture.) As illustrated in Figure 4 below, these clinical risk factors are independently predictive of hip fracture risk. In other words, for a given BMD, individuals with more risk factors have a higher likelihood of suffering a hip fracture.
Figure 4. Clinical Risk Factors Independently Predict Hip Fracture Risk
[d]
Source: Cummings SR; Nevitt MC; Browner WS; Stone K; Fox KM; Ensrud KE, et
al. Risk factors for hip fracture in white women. N Eng J Med 332(12):767-773, 1995.
Looking to the future in the field of diagnosis, Dr. Black noted that there is a movement to use fracture risk for diagnosis and to decide whether an individual needs treatment. Using BMD and other risk factors, the risk of fracture can be accurately predicted. Ongoing efforts to redefine diagnosis based on risk are currently underway; they have the potential to unify diagnosis across gender, ethnic groups, and countries. But several challenges remain, including how to integrate the risks and consequences of various fracture types, and how to alter treatment recommendations based on fracture risk. At present, treatments such as bisphosphonates have been shown to prevent nonspine and hip fractures only in those with low BMD. Thus, it is not clear what treatment, if any, will be effective for an individual who has normal BMD but has other risk factors. Other controversial issues in diagnosis include how to apply t-score categories to men and non-Caucasian women, determining optimal BMD values for treatment and optimal use of fracture risk for diagnosis, and determining the proper role (if any) for peripheral densitometry. On this latter point, Dr. Black suggested that peripheral BMD measurement could be used as a pre-screening device to raise awareness among the public.
Susan Greenspan,
M.D.
Osteoporosis Prevention and Treatment Center
Clifford Rosen, M.D.
St. Joseph Hospital
Dr. Greenspan illustrated the challenge in preventing fractures. As shown in the chart below, the goal is to prevent the young, normal bone from becoming osteoporotic bone. But when osteoporosis does occur, treatments can help to reverse this evolution, making a previously brittle bone stronger. These treatments include antiresorptive therapy that helps prevent bone loss, anabolic therapy that helps build bone, and combinations of therapies, such as two antiresorptive therapies or an antiresorptive therapy combined with an anabolic therapy. One key issue with combination therapy is whether to use the therapies at the same time (concurrently) or one after the other (sequentially).
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Source: Image courtesy of Ralph Müller, Ph.D., Switzerland, ETH and
University Zürich.
Dr. Greenspan and Dr. Rosen reviewed the evidence to date on a variety of antiresorptive and anabolic therapies. Dr. Greenspan cautioned that there is little data that allow for head-to-head comparisons between therapies. She also noted that most studies evaluate improvements in BMD, which are not directly correlated with fracture reduction. That said, evidence suggests that the greater the improvement in BMD, the greater the fracture risk reduction (even though changes in BMD account for only about one-third of overall risk).
Antiresorptive Therapies
Antiresorptive therapies prevent bone loss and can stabilize the microarchitecture of the bone, which in turn leads to a decreased risk of fracture. Bisphosphonates such as alendronate and risedronate are among the most common antiresorptive therapies. These drugs have been shown to increase BMD at the hip and the spine, leading to a 40% to 50% reduction in spine and hip fractures over a three-year period. Evidence suggests that the benefits accrue in as little as one year for spine fractures and 18 months for hip fractures, with benefits lasting up to 10 years with alendronate and five years with risedronate. Importantly, higher BMD continues for at least several years following discontinuation of the treatment. Benefits have been shown in post-menopausal women and men with osteoporosis, patients with glucocorticoid-induced bone loss, and patients with Paget's Disease and OI. One problem with bisphosphonate therapy, however, is that the drugs are difficult for the body to absorb. Current therapies involve taking an oral medication once a week. The future may allow for a once-a-year intravenous administration of the drugs.
Hormone replacement therapy (also known as HRT or ERT for estrogen replacement therapy) has also been shown to increase BMD at the spine and hip, and to reduce the risk of spine and hip fracture in older women by 34%. Unfortunately, however, significant bone loss has been found to occur shortly after discontinuation of the therapy. This bone loss may “wipe out” any gains from the treatment. HRT has been used in postmenopausal women and women with glucocorticoid-induced osteoporosis. The key issue with HRT is whether the risks exceed the benefits. The findings from the Women's Health Initiative (WHI) suggest that HRT increases events related to heart disease as well as the risk of stroke and breast cancer. Looking ahead, the development of new types and doses of HRT may address some of these risks. Interestingly, the combination of ERT and alendronate has been found to have a greater impact on BMD in postmenopausal women than either agent used alone, and the benefits appear to continue after the therapy is discontinued. But no data exist on the impact of this combination therapy on fracture reduction. Looking ahead, studies of various combinations of this treatment must be evaluated to determine its impact on fractures and its cost-effectiveness versus other treatments.
Dr. Rosen noted that selective estrogen receptor modulators or SERMs work in a manner similar to estrogen. They have been shown to increase BMD at the hip and spine and to reduce spine fractures by 50% in postmenopausal women (although they appear to have no impact on hip or nonspine fractures). Efficacy begins three years after a treatment begins, but bone loss occurs after discontinuation of treatment. SERMs are an oral therapy that is well absorbed and causes no menstrual bleeding. Like estrogen, SERMs increase the risk of venous thromboembolisms and may result in an increase in hot flashes. But they may actually decrease the risk of breast cancer. Looking ahead, researchers will test SERMs with different risk-benefit ratios, and will further evaluate their impact on nonspine fractures.
Calcitonin is an easy-to-take, well-tolerated medication that has been shown to increase BMD at the spine modestly in postmenopausal women. One dose has been shown to decrease the risk of spine fractures by 36% (although this finding is controversial), with no reduction in the risk of hip fractures.
Anabolic Therapies
Anabolic therapies build bone. PTH (parathyroid hormone) was approved by the Food and Drug Administration (FDA) on November 27, 2002. PTH has been shown after 18 months of treatment to increase BMD at the spine and hip and to reduce the risk of spine fractures by 65% and nonspine fractures by 50%. While definitive evidence is not yet in, the treatment appears to be effective for men and postmenopausal women with osteoporosis, as well as for patients with glucocorticoid-induced osteoporosis who have failed other forms of treatment. Not surprisingly given the newness of the medication, several issues remain to be resolved, including the best way to administer the medication (it is currently injected daily), when and how to check blood calcium levels, and whether to use PTH alone or with other antiresorptive therapy. Looking ahead, other forms of PTH and other modes of administration are likely to be developed. For example, in early 2004 another form of PTH that may offer even greater potential to build bone will likely be submitted to the FDA for review. But since PTH costs $20 per day (or $7,200 per year), one critical issue is who to treat. Data suggest that postmenopausal women with a t-score that is two or more standard deviations below peak bone mass (1.5 or more standard deviations if other risk factors exist) can benefit, as can men with diagnosed osteoporosis. PTH is relatively effective versus alternatives in preventing spine fractures in high-risk patients, but like many other treatments has not yet been proven effective in low-risk individuals.
Combinations of Anabolic and Antiresorptive Therapies
A handful of therapies combining anabolic and antiresorptive approaches have been tested, including one that found that use of PTH and HRT is better than HRT alone. A study of PTH combined with bisphosphonate is not yet completed.
Conclusion
Dr. Rosen concluded by noting that there are effective therapies available to increase BMD and reduce spine and hip fractures. That said, the therapies differ in terms of the fracture sites they address, the amount of time that treatment lasts (and when signs of efficacy begin), and the impact on bone mass after discontinuation of therapy. Key issues to be resolved include who needs this type of preventive therapy (including what BMD cut-off should be used for men and nonwhite ethnic groups), how long treatment should last, what bone mass needs to be achieved, and whether the “cycling” of therapy (i.e., a period of treatment, followed by discontinuation for a period of time, followed by treatment again) makes sense. Looking ahead, Dr. Rosen called for the development of better guidelines to address these issues.
Henry G. Bone, M.D.
Michigan Bone and Mineral Clinic
Dr. Bone reviewed how drugs for bone disease are developed and approved. He began by describing the key measures that are used to determine a drug's efficacy at various stages of development. Early testing focuses on pharmacology measures, including blood and urine levels that help to estimate drug absorption, metabolism, and excretion. In addition, biochemical markers are measured as a means of determining the drug's impact on bone metabolism. Later in the process, the drug's impact on bone density is measured at multiple sites. This clinical test is considered very important, since bone mass is a major mechanical determinant of strength and, as noted earlier, is highly predictive of fracture. Fracture rates, however, remain the ultimate clinical outcome. Spine, nonspine, and hip fractures are typically considered separately.
Pre-clinical drug development involves the screening of millions of compounds to find one or a few that have an effect on bone. Once a compound with strong potential is discovered, it is tested on animals to determine the impact on pharmacology and toxicology. Assuming these trials suggest that the compound is safe and potentially effective, human clinical trials begin. Phase I testing involves evaluation of short-term pharmacology and safety issues in healthy individuals. The primary goal is to determine if the drug can be safely tolerated. Phase II may be the most important part of the testing, as it focuses on efficacy, dose-finding, tolerability, and the impact of the drug on biochemical markers and BMD. Roughly 1,000 individuals are involved in this phase for a period of approximately one year. Phase III may involve anywhere from 5,000 to 20,000 individuals. These trials focus on making a definitive determination of the drug's efficacy and safety, including its three-year impact on BMD and fracture rates at different skeletal sites.
Looking ahead, Dr. Bone urged drug companies and regulators to make sure that drug evaluation is as efficient as possible while still maintaining reliability. He emphasized the importance of rigor during phase II trials designed to determine the appropriate dose, and urged reconsideration of statistical requirements for evaluation of the impact of drugs on secondary fracture sites (if the drug has been proven successful at a primary site). He also called for greater coordination between the U.S. and EU regulatory authorities, and reminded drug developers and regulators not to forget about drug treatments for bone diseases other than osteoporosis.
Eric Orwoll, M.D.
Oregon Health Sciences University
Despite the conventional wisdom that osteoporosis is a “woman's disease,” many men are affected as well. Just over 13% of men aged 50 will have a fracture sometime in their life. While BMD is a good predictor of fracture risk in men, there are no set criteria for determining when men have osteoporosis and therefore need treatment. Using the same criteria that define osteoporosis in women, roughly one in seven men over the age of 80 has the disease.
Men get osteoporosis for a variety of reasons, although one-third to one-half of the cases are primarily the result of genetics. Environmental factors also play a role, including alcoholism. Men with prostate cancer who are being treated with androgen deprivation therapy are also at greater risk of bone loss.
Treatments such as alendronate and PTH have been shown to markedly increase BMD and reduce the risks of fracture in men (see Figure 6). But men are much less likely to have the disease diagnosed and treated, even after a fracture occurs (see Figure 7).
Figure 6. Therapy in Osteoporotic Men
[d]
Sources: Orwoll E; Ettinger M; Weiss S; Miller P; Kendler D; Graham J, et al.
Alendronate for the treatment of osteoporosis in men. N Engl J Med 2000 Aug 31;
343(9):604-10.Orwoll E; Belknp JK; Stein RK. Gender specificity in the genetic determinants of peak
bone mass. J Bone Miner Res 2001 Nov; 16(11):1962-71.Figure 7. The Care of Men After Fracture
[d]
Sources: Feldstein et al. In press.Kiebzak GM; Beinart GA; Perser K; Ambrose CG; Siff SJ; Heggeness MH.
Undertreatment of osteoporosis in men with hip fracture. Arch Intern Med 2002
Oct 28; 162 (19):2217-22.
Jane Cauley, Ph.D.
University of Pittsburgh
Caucasian women have higher rates of osteoporosis than do African-Americans and Asians, but the rate of bone loss in all ethnic groups increases with age. (Differences in body weight and the length of the hip axis appear to be important factors in explaining differences in BMD across ethnic groups.)
African-American women are more likely than Caucasian women to die from a fracture. Risk factors for African-American women are similar to those for Caucasians and include having low body weight in relation to height (a condition known as low body mass index or low BMI—a reading below 22.6 raises the risk of hip fracture by 13.5 times), alcoholism (consuming more than seven drinks a week raises the risk of hip fracture by 4.6 times), a history of stroke (which raises the risk of hip fracture by 3.6 times), and use of ambulatory aids (which raises the risk of stroke by 5.6 times). Each one-standard-deviation decrease in BMD in African-American women raises the risk of fracture by 80%, compared to 40% for Caucasian women. Fortunately, treatments for osteoporosis appear to be effective in African-American women. A study of alendronate, for example, found that the benefits of the drug to African-American women were similar to the benefits for Caucasian women. Dr. Cauley noted that further study is needed on the efficacy of various therapeutic agents across ethnic groups.
Nelson Watts, M.D.
Osteoporosis Center, University of Cincinnati
Bone diseases are often silent conditions that exist for years before any obvious signs manifest (e.g., a fracture). The only way to definitively diagnose the disease is through a bone density test. One of the barriers to testing is coverage, since the cost of the test is relatively high. Since July 1, 1998, Medicare has covered baseline bone density testing for certain individuals that are deemed to be at risk for bone disease (e.g., estrogen-deficient women, patients with abnormalities of the spine, patients receiving long-term glucocorticoids, and patients with primary hyperparathyroidism). Payment is based on diagnoses, which are conveyed by a complex set of codes that are used inconsistently. Along with a lack of insurance coverage, the inability to travel to a testing center may also limit access to diagnostic testing. While the nation has an adequate number of central DXA machines to adequately meet the needs of the 35 million Americans—including 20.5 million women over the age of 65 and 10 million men over the age of 70—who likely need to be screened on a regular basis, the geographic distribution of these machines may make it difficult for individuals in rural regions to get access to a test.
Assuming that individuals are screened, effective pharmacologic therapies for osteoporosis are available. But coverage of these therapies by private insurance is inconsistent, while none of these drugs is covered by Medicare in the outpatient setting. Nonpharmacologic treatments such as calcium and vitamin D, physical therapy, and hip protectors, are also not typically covered.
Dr. Watts noted that the limits to access to screening and treatment for osteoporosis are similar to problems in financing and delivering care for the prevention of other chronic diseases. Looking ahead, he hopes for the development of new diagnostic strategies that are less costly, and for changes in coding and reimbursement to improve access to testing and treatment.
Ethel Siris, M.D.
Columbia University
Access to screening and treatment for osteoporosis begins with awareness of the problem. Dr. Siris shared data from the National Osteoporosis Risk Assessment (NORA) study, which assessed the scope of the problem of osteoporosis and osteopenia in women. This study evaluated 200,000 postmenopausal women without known osteoporosis. All women completed questionnaires on risk factors and had a BMD performed at a single peripheral site (the heel, forearm, or finger) at baseline. The study found that 7.2% of the study population had osteoporosis (defined as a t-score 2.5 or more standard deviations below peak bone mass), while 36.9% had low bone mass (defined as between 1.0 and 2.49 standard deviations below peak bone mass). Bone mass scores declined with age in all ethnic groups, including Caucasians, Asians, African-Americans, Native Americans, and Hispanics. Similarly, fracture rates were significantly higher for those with the lowest t-scores in all ethnic groups (see Figure 8). Perhaps the most interesting finding from the study was that even though the risk of fracture is much higher in individuals with osteoporosis, the greatest absolute number of fractures occurred in individuals with low bone mass (since there are roughly five times more individuals with low bone mass than with osteoporosis). Dr. Siris emphasized the importance of finding ways to diagnose and help these individuals as well as those with osteoporosis.
Figure 8. Osteoporotic Fracture Rates, Population BMD Distribution
and Number of Fractures
[d]
Source: Siris ES, Miller PD, Abbott TA, Chen Y, Faulkner K, Barrett-Connor E, Berger
M, Santora A, Sherwood L. J Bone Miner Res 2001; 16:Suppl 1, S337.
The panel included a presentation from an individual whose personal story highlights the need for better tools for diagnosing and treating osteoporosis.
Annie Lorigan
Ms. Lorigan is a 73-year-old woman with a long history of osteoporosis. She
suffered her first fracture 18 years ago, and since that time has had eight
additional fractures, each of which caused tremendous pain and required hospital
stays and long periods on various medications. Unfortunately, Ms. Lorigan does
not tolerate many osteoporosis medications very well. As a result, her treatment
consists primarily of estrogen, Vitamin D, and calcium supplements.
Osteoporosis affects every part of her life. She must limit the time she spends
with her grandchildren, as well as the types of activities she can enjoy with
them. (She has fractured her back three times while playing with her grandchildren.)
She finds it impossible to lie down on her back or right side, and finds it
difficult to get in and out of bed or a chair. She has had to give up dancing,
one of her favorite activities, and feels she has become a “drag” on
family members who must slow down to accommodate her limitations.
Ms. Lorigan called for the following actions: a national education campaign focusing on early diagnosis of osteoporosis and other bone diseases (modeled after the diabetes campaign), development of new medications that are easier to tolerate, and greater understanding, patience, and compassion among doctors.
The third panel and the luncheon presentation and discussion focused on ways to promote awareness and action among the public and health care professionals. The panel was chaired by Lynne Wilcox, M.D., M.P.H., of the Centers for Disease Control and Prevention (CDC).
Edward Maibach, Ph.D., M.P.H.
Porter Novelli
Dr. Maibach summarized three decades of experience on education programs and behavior change with five key observations:
First, public education works, as suggested by massive secular trends in smoking rates, use of seat belts and child safety seats, cancer screening rates (e.g., mammography), and incidence of sudden infant death syndrome or SIDS. But he cautioned that public education tends to work slowly (over a period of 5 to 10 years) and that some health behaviors are more easily influenced than others through public education. For example, the SIDS campaign was effective because it targeted a highly motivated audience (parents concerned about the safety of their infant children) and because the requested behavior change was easy (putting the child to sleep on his or her back). Changing physical activity levels is a much more complex and challenging task that may take decades to achieve.
Second, the “general public” is not a valid definition of the target audience. Different people have different educational needs, and those embarking on a public education campaign must segment the audience into homogenous subsets of people, tailoring educational efforts to the extent possible to each group's unique needs.
Third, education is not equivalent to motivation or behavior change. Knowledge gained through education does not automatically result in a change in attitude or behavior. Education requires the development and delivery of simple, clear messages that are frequently repeated. Motivation requires finding the “difference that makes a difference.” Behavior change is more likely to occur with education, motivation, and the ability to make change.
Fourth, the process works best when three critical assets are used: campaigns that are based on evidence of proven effective interventions, behaviors, or procedures; behavioral science that helps understand why people do what they do and what can be done to help them change; and consumer research that ensures that programs are relevant, credible, and motivating. Dr. Maibach warned against getting ahead of the evidence base, and cautioned that failure to conduct consumer research may cause a campaign to fail.
Fifth, the most effective campaigns are “big, messy” programs that include contributions from all sectors of society (e.g., government, nonprofit, and for-profit organizations) and a multitude of communication vehicles and program elements. That said, leadership often comes from one or a few organizations, as evidenced by the successful educational campaign on blood pressure spearheaded by the National Heart, Lung, and Blood Institute (NHLBI).
David Chambers, Ph.D., M.Sc.
National Institute of Mental Health
Dr. Chambers reviewed key issues in disseminating new information to the public. First and foremost, he reiterated the point made by other speakers—that information presented to an audience will not necessarily lead to behavior change. Everyone does not interpret information in the same way, and the importance of information will be related to the context in which it is disseminated. Information may evolve over time, and many individuals might choose to challenge the information being presented. Developers of education campaigns should keep tabs on changes in the field and be prepared to respond to any challenges to data or other information that is included in an awareness campaign.
Questions to be considered when developing a campaign to disseminate new information include the following:
Dr. Chambers recommended that those planning an information dissemination campaign use active and interactive methods rather than passive ones (e.g., handing out paper); involve target audiences in planning the dissemination campaign; use multiple disciplines in designing the dissemination plan; and track the outcomes of the dissemination campaign (including who received the information and whether knowledge has been gained).
Dr. Chambers also urged campaign developers to take advantage of important contributions from other fields, including social marketing (e.g., for "packaging" of messages), behavioral change (for "using" the information), organizational culture, anthropology (to help determine how different communities will react), organizational change, and finance/economics (to craft economic arguments for behavior change).
Richard Kravitz, M.D.,
M.S.P.H.
University of California, Davis
Dr. Kravitz believes that the private sector’s financial resources and ability to reach a huge market can be brought to bear on the public health issue of bone health. Spending on direct-to-consumer (DTC) advertising reached roughly $7.5 billion in 2000, and is expected to continue growing rapidly. DTC apparently works–drugs with the largest DTC budgets enjoy the highest sales increases, while several studies show that DTC ads are read and acted upon. For example, a random digit dial survey in Sacramento found that 56% of respondents had read an entire DTC ad. More than a third (35%) asked their physicians for more information on the drug, while 19% asked for a prescription. A binational clinic survey suggests that patients who request a prescription have an 8.7 times higher chance of getting one, even though physicians are much more ambivalent about the need for the drugs their patients request (versus those they prescribe without patient input).
Dr. Kravitz sees potential harms and benefits in DTC advertising. On the positive side, DTC advertising encourages patients to seek care when needed and allows for more informed decision making, more active involvement in care planning, and a greater understanding among patients of their conditions. At the same time, however, DTC advertising may encourage the "over-medicalization" of certain conditions and lead to too-low thresholds for when a condition requires treatment. Most important, perhaps, physicians who are inundated with questions from patients may find themselves with inadequate time to address other, more pressing clinical needs among patients.
But both the critics and the proponents of DTC advertising agree that the benefits will outweigh the risks for conditions which are under-diagnosed and under-treated, and when the net benefits of treatment are evident even among less severely affected individuals. Osteoporosis is clearly under-diagnosed and is under-treated among certain populations, including men. But the absolute benefits of treatment are clearly dependent upon the baseline risk, with high-risk individuals benefiting much more from treatment than those at lower risk. As a result, the educational value of DTC advertising can be enhanced by targeting those groups with the highest absolute risk of osteoporosis, such as elderly women and those with a previous fracture. The educational value can also be enhanced by describing benefits and risks in understandable, quantitative terms (many DTC ads do not do this at present), and by portraying drugs as playing an important role in an overall package of care for osteoporosis, a package that may also include calcium, vitamin D, exercise, and hip protectors.
Sara S. Johnson, Ph.D.
Pro-Change Behavior Systems, Inc.
Dr. Johnson presented a transtheoretical (TTM) model for behavior change that emphasizes the importance of matching interventions to an individual’s readiness for change. There are five stages of change in this model–pre-contemplation, contemplation, preparation, action, and maintenance. In other words, behavior change is a process. While an education campaign can initiate this process, it cannot sustain it. Stage-matched interventions and campaigns are needed for all levels, including those directed at individuals, providers, and communities.
Dr. Johnson shared the results of a study that applied the TTM to osteoporosis prevention and management. This survey found that 25% to 57% of individuals were in the pre-action stage with respect to key behaviors related to osteoporosis and bone health. Among these individuals, 34% to 57% were in the pre-contemplation stage. The implications from this study are clear–while a large proportion of the population may be at risk of osteoporosis and bone disease, many of these individuals are not currently contemplating behavior changes that could reduce this risk.
Changing behavior to reduce the risk of osteoporosis and bone disease is a multivariate problem requiring multivariate solutions. The process can be accelerated by matching interventions to the target audience’s readiness for change. Scientifically valid assessments can be created to measure stage, thus allowing interventions to be targeted appropriately. As a result, tailored messages can be delivered to diverse populations. But the challenge is to go beyond education to develop population-based programs for each of the behavior changes that are important to improving bone health.
Deborah Gold, Ph.D.
Duke University Medical Center
As increased life expectancy puts more people at risk for osteoporosis, the need for early, accurate diagnosis becomes more critical. While osteoporosis can be reliably diagnosed, treated, and prevented, it often goes unnoticed in patients, leading to severe physical, social, functional, and psychological consequences, including increased mortality and morbidity. Thus, improving the diagnosis and treatment of osteoporosis is a major challenge and priority for health care professionals.
Unfortunately, physicians and other professionals receive relatively little training about osteoporosis and bone health. At the undergraduate level, pre-clinical training may cover osteoporosis during study of the pathophysiology of the endocrine and/or musculoskeletal system. Osteoporosis may also be touched upon in a case presentation or standardized patient interview, and may be included in certain rotations. But overall, health professions students spend less than an hour studying osteoporosis during their undergraduate days.
The situation is little better during residencies and fellowships. Residents and fellows in most specialty areas rarely see a patient with osteoporosis. Primary care residents have little opportunity to treat osteoporosis and fractures (especially spine fractures), since most spine compression fractures are treated on an outpatient basis outside of academic teaching centers, and hip fractures are treated by orthopedic surgeons. Even residents and fellows in endocrinology and rheumatology have little exposure to the disease.
Once a physician finishes his or her formal education, continuing professional education on osteoporosis is available from a variety of sources in a variety of formats, including through provider web sites that link to the sponsors of such programs (e.g., the National Osteoporosis Foundation). Many courses are funded by unrestricted grants from corporate sponsors. While some health professionals are uncomfortable with such funding, Dr. Gold believes that these programs are generally of high quality.
Looking ahead, Dr. Gold cautioned against relying on information alone. While many health professionals have inadequate knowledge about osteoporosis and how to identify and treat it, an additional problem is the failure to apply what knowledge they do have in patient care settings. Thus, both information and application need to be stressed in all training of health professionals.
Edward Roccella, Ph.D., M.P.H.
National High Blood Pressure Education Campaign
Dr. Roccella shared insights from the National Heart, Lung and Blood Institute’s (NHLBI) highly successful education campaign on high blood pressure that may be applied to any similar type of campaign on osteoporosis. The NHLBI campaign has been instrumental in dramatically increasing knowledge about blood pressure, which has led to a tripling in blood pressure control rates since the campaign began. Lessons of relevance to bone health include the following:
The panel included two presentations from individuals whose illnesses illustrate the real need for greater awareness about bone disease among the public and the medical profession.
Judge Jewel Lewis
In the late 1970s, Judge Lewis was diagnosed with Paget’s Disease, a disease that affects bones by causing calcium loss in the spine (the calcium is redeposited elsewhere in the body, often the skull). At the time of her diagnosis, Judge Lewis was 5'8" tall. She was informed by doctors that there was no treatment for the disease, and that her fate was to become "a little old lady with bowed legs." Today she is 84 years old and a foot shorter, but has not yet developed bowed legs. She has suffered a series of spine fractures, however. After finding that none of the treatments she tried as an NIH research subject worked, her primary treatment today is exercise, calcium, and vitamin D.
Paget’s Disease has had a profound impact on Judge Lewis’ life. Because she traveled for her job as a Federal administrative judge, she was forced during her time as part of the NIH research trial to carry around a refrigerated bag with her medications. Having access to this bag at all times was critical to complying with NIH’s rigid medication schedule. She is presently being treated for angina and hearing loss, both of which are a result of Paget’s Disease. Looking ahead, she urged the development of education campaigns for both the general public and the medical community on this terrible disease. She also called for frequent testing and early treatment for those with the disease.
Thomas G. Carskadon
A psychology professor and an advocate for research and screening for osteoporosis, Dr. Carskadon served as the "token male" on the panel. His story is a classic example of the failure of the medical profession to appreciate the potential for severe osteoporosis in men. When he first sprained his ankle many years ago, the doctor told him he may have a "little osteoporosis" and that he should take calcium so that the bone can "grow back." It was not until years later, however, that he finally received a bone scan that showed he had severe osteoporosis. At this time, he continues to take bisphosphonates, which have helped him regain a bit of bone density. His BMD is presently stable, albeit at a very low level. Osteoporosis has had a profound effect on his life. He is constantly afraid of falling, and as a result seriously curtails his activities (e.g., he gave up running).
I had a slew of warning signs but no one
picked it up."— Thomas G. Carskadon
Dr. Carskadon made an impassioned plea to get the word about osteoporosis in men out to the public and to the caregivers on the front lines of medicine, and for the development of formal guidelines for screening and treatment of the disease in men. Noting that it costs only $150 for a test that can very accurately diagnose osteoporosis, he also called for revisions to existing guidelines to make bone density tests more widely available. The failure to spend $150 today to diagnose the disease in its early stages will inevitably lead to higher costs later in life when fractures occur. As he noted, "you can pay now or pay me later."
Susan Dentzer
The NewsHour with Jim Lehrer
During lunch, Ms. Dentzer expanded on the issue of education and awareness by discussing the role of the news media in telling the "hard truth" about osteoporosis. Ms. Dentzer was introduced by Stephen Katz, M.D., Ph.D., Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, who noted that Dr. Elias Zerhouni, director of the National Institutes of Health, often urges his team of institute directors to "communicate, communicate, communicate!"
Ms. Dentzer believes that osteoporosis should be a major story in the media. With 10 million Americans having the disease, another 34 million at risk of developing it, and 1.5 million fractures occurring each year because of it (at a cost of $15 billion a year), the media should be jumping on this story. If that is not enough to get the media interested, the growing costs of osteoporosis–projected to reach $50 billion by 2040–and its association with other common conditions such as depression, lack of mobility, social isolation, and disability, should be.
Yet neither the medical community nor the media appear to be paying attention to the disease. Many doctors do not believe that osteoporosis is as big a threat to health as other diseases, such as cardiac disease, cancer, or diabetes. Many physicians, unaware of the death and disability caused by osteoporosis, view the condition as a normal part of aging. Perhaps because of this indifference among the medical community, mainstream media is also not paying much attention to osteoporosis. A review of recent literature suggests a paucity of comprehensive media coverage compared to other major diseases such as heart disease and diabetes. Ms. Dentzer’s own unscientific review of the literature found only 20 stories of a comprehensive nature since January 2001. Much more common are situations where osteoporosis receives a brief mention in a story about general women’s health issues. A good example of this approach can be seen in the recent coverage of the end of the combination hormone replacement therapy trial in the Women’s Health Initiative or WHI.
The big problem with coverage of osteoporosis is that journalists have not yet been able to "put a face" to the disease. The most popular health stories are based on anecdotes about individual patients. But even though osteoporosis affects millions–including well-known individuals like Ronald Reagan and Julia Child–there have not been any "celebrity" spokespersons for the disease, perhaps because of social stigma or the disease’s association with aging. In fact, in an era of "disease by celebrity," there has been just one public face so far–Lauren Hutton in Wyeth’s commercials for HRT. But even in this instance, osteopenia and osteoporosis are not mentioned by name in the ads.
Ms. Dentzer also noted that it takes systematic coverage over a long period of time to get a story out to the public in a way that they truly understand. For example, a new Partnership for Prevention poll found that 69% of the 1,003 women surveyed (all between the ages of 55 and 70) had heard of or read about the WHI HRT study. Nearly six in 10 (58%) said they were concerned about the risks of HRT. But nearly one-third of the women thought that HRT helped prevent some of the diseases associated with aging, such as heart disease, stroke, and breast cancer. (The study found that HRT actually increased the chances of getting these diseases.)
To get stories on osteoporosis out to the public, Ms. Dentzer believes that the news media needs to give osteoporosis and osteopenia a face (including a male face). The media needs to profile people with the disease, explaining what has happened to them with respect to lifestyle, disability, and poverty. The media should also graphically discuss what happens during and after a hip fracture or other bone fracture, and should publicize the large costs of these avoidable conditions. But the media must also acknowledge the limits of current knowledge about screening, prevention, and treatment. The public often becomes disenchanted when new findings contradict old ones. Thus it is critical to be honest about the fact that much is not yet known with respect to preventing and treating bone disease, and that new knowledge will be forthcoming in the years ahead.
With those limits acknowledged, the key challenge is to put forth what is believed to be known about prevention, and to clarify that taking calcium alone is likely not sufficient to solve the problem. These messages should include an emphasis on the role of exercise (especially the weight-bearing variety) in prevention, and should also stress the critical role of exercise with respect to a wide variety of health issues. Ms. Dentzer urged the bone health community to work with advocates for other diseases in developing messages on those behaviors–including diet and exercise–that have an impact that cuts across multiple diseases. Too many disease-specific messages can confuse the public. That said, the media also needs to convey specific information about the pros and cons of screening, including those situations where routine screening is recommended (e.g., for women over the age of 65). The media also needs to communicate the benefits and risks of various treatment options, including drug regimens. Finally, the media needs to get information out to physicians. Ms. Dentzer shared the results of a recent study of 114 women whose BMD tests showed osteoporosis or low bone mass. Even though these results were shared with the women’s physicians, fewer than one in 10 (9.7%) patients received recommendations from their physicians that were consistent with those of NIH and NOF.
In closing, Ms. Dentzer asked health care professionals to help the media in doing a better job. To that end, she called for the Surgeon General’s Report to be written in the clearest language possible. She also suggested that a conference or in-depth briefing be held for journalists in advance of the report’s release. Finally, she asked that knowledgeable professionals make themselves available to the media, and that they share stories on the human suffering caused by osteoporosis as well as the research findings documenting the tremendous costs borne by society and the tremendous opportunities to reduce these costs through better prevention, screening, and treatment. But she cautioned that commercial television will always be most interested in brief "sound bites," and urged health professionals to think about these sound bites when addressing the media. She also reiterated the importance of putting a face to the disease, as the public will tend to remember personal stories, not data.
The fourth panel, chaired by CAPT Allan S. Noonan, M.D., M.P.H., of the Office of the Surgeon General, focused on promising public health prevention strategies. In moderating the session, Dr. Noonan emphasized the diversity of the different programs featured, including individual, community, and state and Federal government approaches. Collectively these initiatives provide a roadmap for how people and organizations can participate in preventing bone disease from a variety of perspectives. He also emphasized that a public health approach to preventing bone disease can ultimately help to reduce costs. Yet today the U.S. spends only 1% of its health care dollar on preventive activities. Governments at all levels—Federal, state, and local—need to increase their commitment to prevention, thereby serving as catalysts for bringing together the community to prevent bone disease and its associated complications for individuals of all ages.
Connie Weaver, Ph.D.
Purdue University
Dr. Weaver reviewed the importance of good diet to building bone and to keeping bones strong. She emphasized the importance of developing healthy behaviors early in life, both because early habits carry on into later life and because there is a narrow opportunity during youth to build bone. Figure 9 illustrates this latter point, showing that the rate of accumulation in both boys and girls rises rapidly until puberty, but then falls off dramatically. Total bone mass continues to grow until later in life. Boys tend to have a steeper accumulation curve than girls, and African Americans tend to accumulate bone at a faster rate than do Caucasians.
Figure 9. Maximal Bone Growth Precedes Peak Bone Mass
[d]
Source: Martin AD; Bailey DA; McKay HA; Whiting S. Bone mineral and
calcium accretion during puberty. Am J Clin Nutr 1997 Sep; 66(3):611-5.
Nutrients and dietary habits help to promote calcium retention and strong bones. By getting enough calcium, vitamin D (vitamin D promotes absorption of the calcium), and other nutrients including phosphates and magnesium, individuals are more likely to build strong bones. A diet that is low in salt and full of fruits and vegetables can help to minimize the amount of calcium loss from the bone via the urine. The net result should be a maximization of peak bone mass, minimal bone loss, and good body weight management. Unfortunately, however, most individuals are not getting adequate levels of calcium. In fact, after age 11, males, and to a greater extent females, fall below recommended levels, as exhibited in Figure 10.
Figure 10. Mean Calcium Intakes Fall Below Recommended Levels
[d]
Source: Connie Weaver.
Christine M. Snow, Ph.D.
Oregon State University
Dr. Snow reviewed the unique role that exercise can play in building bone, preventing falls, and reducing fracture risk. She focused primarily upon exercise during youth and early adulthood (e.g., pre-menopause for women). Load-bearing exercises are central to bone development and maintenance. Bone-building exercises need to be site specific (i.e., they will help build bone in those areas that are the focus of the exercise) and involve "overloading" the bone through increased force and loading rates, which occurs in exercises such as jumping and aerobics. The bone-building benefits of exercise are particularly large in youth. Both impact and resistance exercises have been shown to increase bone mass by 3% to 5% and to alter bone geometry in boys and girls before adolescence. Exercise early in life appears to provide lasting benefits, as adults who engage in impact exercise during their youth have greater bone mass than those who do not.
Adults can benefit from exercise as well. Studies of premenopausal women show that spine loading exercise (e.g., rowing, upper-body lifting) increases bone density by 2% to 3%; use of a weighted vest combined with impact exercise increases hip BMD by 2% to 3% and also improves lower body strength, balance, and power; controlled impact exercises such as jumping increase hip BMD by 3%; and step aerobics and jumping increase spine and hip BMD by 1% to 2%. In some cases, these benefits can accrue with as little as 5 to 10 minutes of exercise, 5 days a week. That said, adults must continue exercising if they want to maintain these benefits. Studies show that adults lose 1% to 3% of bone mass within three to six months of ending an exercise regimen. As Dr. Snow noted, "if adults don’t use it (bone mass), they lose it."
Miriam E. Nelson, Ph.D.
Tufts University
Dr. Nelson expanded upon Dr. Snow’s comments by reviewing the benefits of physical activity in adults over the age of 50. She believes that adequate evidence exists to make the following recommendations to this population: get 30 minutes or more of moderate physical activity on most (preferably all) days of the week; and include a mix of exercises during this physical activity, such as weight-bearing exercises, strength training (two or three times a week), and balance training (to help prevent falls). These recommendations are outlined in Figure 11.
Figure 11. Global Recommendations: Physical Activity
in Middle-Aged and Older Adults (50+ Years of Age)
[d]
Source: Miriam Nelson, Tufts University
The benefits of these types of activities are significant. For example, weight-bearing exercises such as walking are associated with higher bone density. Walking more than a mile every day over long periods of time is associated with slower bone loss, and older women who walk for exercise are 30% less likely to fracture a hip. Other weight-bearing activities such as tennis and gardening are also associated with higher bone density. On a cautionary note, Dr. Nelson noted that most longitudinal studies of short-term walking less than 12 months show little slowing in bone loss; to maximize benefit, walking needs to be long-term and combined with other exercises.
For its part, strength training by older adults is associated with higher bone density and increased muscle strength. Studies indicate that engaging in moderate to strenuous strength-training exercises two or three times a week yields improvements in bone density of 1% to 2%. These exercises can be performed at home or in exercise facilities. Finally (and perhaps most importantly for elderly individuals), balance training helps to improve coordination and balance, and has been shown to reduce falls by 30% to 40%. These exercises can also be performed in the home.
In short, safe, culturally appropriate exercises can be fun and effective. A number of community programs for older women have been developed across the country (e.g., the Growing Stronger Program in Washington, D.C.). These programs–which can be developed wherever seniors congregate–can have a significant impact on bone health, balance, and muscle, which in turn should lead to a reduction in fractures.
Doug Kiel, M.D., M.P.H.
Research and Training Institute
Dr. Kiel reviewed the impact of smoking on bone density and fracture rates. Smoking early in life would not appear to have an effect on bone density in either men or women. After menopause, however, women who smoke lose bone mass at a greater rate than nonsmokers (see Figure 12). The evidence also suggests a causal relationship between smoking and bone density in older men. Smokers also have a greater risk of suffering a hip fracture, particularly as they get older (see Figure 13).
Figure 12. Differences in Bone Density Between Smokers
and Non-smokers
[d]
Source: Law MR; Hackshaw AK. A meta-analysis of cigarette smoking,
bone mineral density and risk of hip fracture. BMJ 1997; 315:841-846, with
permission from the BMJ Publishing Group.Figure 13. The Risk of Hip Fracture in Smokers Increases with Age
[d]
Source: Law MR; Hackshaw AK. A meta-analysis of cigarette smoking,
bone mineral density and risk of hip fracture. BMJ 1997; 315:841-846, with
permission from the BMJ Publishing Group.
On a different but related note, Dr. Kiel also reviewed the rationale for use of hip protectors by older individuals at high risk of a hip fracture. Most hip fractures occur because of falls to the side. Energy absorption in soft tissue may account for 75% of the total energy transmitted during the fall. A hip protector system like a car seat belt or bicycle helmet can help to absorb much of this energy, effectively diverting it from the skeleton. A meta-analysis of six randomized controlled trials showed that hip protectors reduce the risk of hip fractures by as much as 63% to 76%. And unlike pharmacologic therapies that take one or two years before they are effective, hip protectors provide immediate benefits.
Saralyn Mark, M.D.
National Bone Health Campaign, Office of Women’s
Health, Department of Health and Human Services
Dr. Mark reviewed the National Bone Health Campaign, a national social marketing campaign to promote bone health in girls between the ages of 9 and 18 and thus reduce their risk of osteoporosis later in life. The initial focus of the effort is on girls 9 to 12 years of age, an age range that represents a "once-in-a-lifetime" opportunity to build skeletal mass. The campaign’s tailored messages make use of parents and other adults as spokespersons, since they may have influence over the behavior of young girls.
The initiative was based on lessons learned from a series of focus groups designed to understand current knowledge levels and motivating forces among girls and their parents. The focus groups with girls found that they had little knowledge of the health benefits from calcium and physical activity, or of the amount of each they needed to promote bone health. But these girls could be motivated by messages that invoke "power" and "strength"especially if the spokesperson is a strong, bold, confident, active female who is part of a group. Based on this research, the "Powerful Bones, Powerful Girls" campaign name was developed. For their part, parents had little knowledge of the calcium requirements or physical activity requirements for adolescent girls, although they perceived calcium to be good for overall health. (The parents’ primary concern was having their daughters eat a diet that was good for their overall health.) Barriers to achieving a healthy diet rich in calcium were as follows: a perceived need for a large quantity of food to meet the calcium requirements; a lack of time to prepare healthy, calcium-rich meals; inadequate financial resources to buy groceries and other necessities; and a lack of perceived influence over their daughter’s behavior.
The campaign was launched in September 2001. It consists of a web site for girls (www.cdc.gov/powerfulbones), advertising and promotion to girls and parents, and collateral material for girls (e.g., calendars with stickers, water bottles, and pens). Many organizations, including the Girls Scouts, Girls, Inc., and the National Association of School Nurses, are collaborating on the campaign. A web site and collateral materials for parents are currently under development, while a journal for girls will be available during the winter of 2002-2003.
The campaign appears to be reaching many individuals. During the first year, 24 million print media impressions and 986,000 broadcast impressions had been distributed, along with 1.3 million items related to the campaign. The campaign’s award-winning web site was accessed 579,000 times during the year.
John McGrath, Ph.D.
Milk Matters Program, National Institute of Child Health
and Human Development
Milk Matters is a public health education campaign to increase awareness about the importance of calcium in the diets of children and adolescents. It was launched in response to growing evidence on the importance of calcium to health and the failure of children and adolescents to get adequate levels in their diets. The campaign targets health professionals and parents (as gatekeepers that influence children) as well as children and teenagers who consume calcium. The goals of the program are threefold: to create awareness of the importance of calcium in building strong bones and a healthy body, and of milk as an excellent source of calcium; to increase knowledge about the importance of beginning osteoporosis prevention in childhood; and to change attitudes about the role of milk and other dairy foods in the diet as a source of calcium. The campaign does not make behavior change an explicit goal; the campaign’s leaders felt that it was unrealistic to expect an educational campaign to have a significant influence on consumption, since its budget is small and the dairy industry funds major efforts to promote consumption of dairy products.
The primary strategy for reaching these goals is involvement and fun. For parents and health professionals, the campaign has used credible sources to develop informational products to help influence children (and in the case of health professionals, their parents). For children and teens, the campaign includes a variety of fun activities (e.g., a coloring book, a web site geared to young people) as well as educational messages that speak to children in their language through channels that they value.
Bess Dawson-Hughes, M.D.
National Institutes for Health Osteoporosis and Related
Bone Diseases - National Resource Center
Founded in 1994, the NIH Osteoporosis and Related Bone Diseases National Resource Center is funded by NIAMS and six other NIH institutes and offices and is operated by NOF in partnership with the Paget and Osteogenesis Imperfecta Foundations. Headquartered in Washington, D.C. in the NOF offices, the center’s mission is to increase knowledge about osteoporosis and related bone diseases, including knowledge of primary and secondary prevention strategies, diagnostic tools, and treatment options. Within the past year, the center has received 32,000 requests for information, one-third of which were from doctors.
The center is constantly focused on identifying and addressing gaps in knowledge about osteoporosis. One of the recent challenges has been to understand and reach a new audience girls and their parents. To that end, the center has been developing culturally appropriate programs and materials targeting Hispanic girls, older Hispanic women, and older Asian women. The center is currently focused on addressing another large gap the failure to test for (and when appropriate treat) osteoporosis in individuals with osteoporotic fractures. At present only 5% of such individuals receive testing or treatment. Through partnerships with the American Academy of Orthopedic Surgeons and other organizations, the center is distributing educational materials to physicians, patients, and family members. The materials are free of charge and are formatted to allow for easy reproduction (e.g., they can be downloaded from the center’s web site).
Dr. Dawson-Hughes expressed her hope that the center could use the upcoming Surgeon General’s Report as a new, fresh catalyst for the development and dissemination of effective messages about osteoporosis, including educational materials and model programs. Dr. Noonan endorsed this strategy, noting that the Surgeon General’s Report should not be viewed as an end in and of itself, but rather as a foundation on which to build a wide variety of programs to promote bone health.
Suzanne Feetham, Ph.D., R.N., F.A.A.N.
Bureau of Primary Health Care
Dr. Feetham described the role of the Health Resources and Services Administration (HRSA) in addressing two critical, related issues for the future of bone health increasing access to care and reducing health disparities across ethnic and racial groups. HRSA, also known as the "Access Agency," seeks to improve the nation’s health by assuring equal access to comprehensive, culturally competent, quality health care for all. As a safety net for U.S. health care, HRSA also assures the availability of quality health