Recommendations and Rationale
Screening for Osteoporosis in Postmenopausal Women
By the U.S. Preventive Services Task Force (USPSTF)*
Address correspondence to: Chair, U.S. Preventive Services Task
Force; c/o Project Director, USPSTF, Agency for Healthcare Research and Quality
(AHRQ); 540 Gaither Road; Rockville, MD 20850; E-mail: .
*This statement summarizes the current U.S.
Preventive Services Task Force (USPSTF) recommendations on screening for
osteoporosis and the supporting scientific evidence, and it updates the 1996
recommendations contained in the Guide to Clinical Preventive Services,
second edition.1
Explanations of the ratings and of the strength of overall evidence are given in
Appendix
A and Appendix
B, respectively. The complete information on which this statement is based,
including evidence tables and references, is available in the accompanying
article, “Screening
for Osteoporosis: A Review of the Evidence for the U.S. Preventive Services Task
Force“2
and in the Systematic Evidence Review3
on this topic, which can be obtained through the USPSTF Web site (http://www.preventiveservices.ahrq.gov/)
and in print through the AHRQ Publications Clearinghouse (call 1-800-358-9295)
or E-mail .
Recommendation and Rationale statements present the current USPSTF
recommendations, the rationale for the recommendations, and the supporting
scientific evidence. These statements address preventive health services for use
in primary care clinical settings, including screening tests, counseling, and
chemoprevention.
The USPSTF recommendations are independent of the U.S. Government. They do
not represent the views of the Agency for Healthcare Research and Quality
(AHRQ), the U.S. Department of Health and Human Services, or the U.S. Public
Health Service.
Contents
Summary
of Recommendations
Clinical
Considerations
Scientific
Evidence
Recommendations
of Others
Appendix
A. USPSTF Recommendations and Ratings
Appendix
B. USPSTF Strength of Overall Evidence
References
and Notes
Acknowledgments
Reprints
Summary of Recommendations
The U.S. Preventive Services Task Force (USPSTF) recommends that women aged
65 and older be screened routinely for osteoporosis. The USPSTF recommends that
routine screening begin at age 60 for women at increased risk for osteoporotic
fractures (see “Clinical Considerations” for discussion of women at increased
risk). B
recommendation.
The USPSTF found good evidence that the risk for osteoporosis and fracture
increases with age and other factors, that bone density measurements accurately
predict the risk for fractures in the short-term, and that treating asymptomatic
women with osteoporosis reduces their risk for fracture. The USPSTF concludes
that the benefits of screening and treatment are of at least moderate magnitude
for women at increased risk by virtue of age or presence of other risk
factors.
The USPSTF makes no recommendation for or against routine osteoporosis
screening in postmenopausal women who are younger than 60 or in women aged 60-64
who are not at increased risk for osteoporotic fractures. C
recommendation.
The USPSTF found fair evidence that screening women at lower risk for
osteoporosis or fracture can identify additional women who may be eligible for
treatment for osteoporosis, but it would prevent a small number of fractures.
The USPSTF concludes that the balance of benefits and harms of screening and
treatment is too close to make a general recommendation for this age
group.
Clinical Considerations
- Modeling analysis suggests that the absolute benefits of screening for
osteoporosis among women aged 60-64 who are at increased risk for osteoporosis
and fracture are comparable to those of routine screening in older women. The
exact risk factors that should trigger screening in this age group are
difficult to specify based on evidence. Lower body weight (weight < 70 kg )
is the single best predictor of low bone mineral density.4,5
Low weight and no current use of estrogen therapy are incorporated with age
into the 3-item Osteoporosis Risk Assessment Instrument (ORAI).4,5
There is less evidence to support the use of other individual risk factors
(for example, smoking, weight loss, family history, decreased physical
activity, alcohol or caffeine use, or low calcium and vitamin D intake) as a
basis for identifying high-risk women younger than 65. At any given age,
African-American women on average have higher bone mineral density (BMD) than
white women and are thus less likely to benefit from screening. Additional
characteristics of screening tools are discussed in the “Accuracy
and Reliability of Screening Tests” section. - Among different bone measurement tests performed at various anatomical
sites, bone density measured at the femoral neck by dual-energy x-ray
absorptiometry (DXA) is the best predictor of hip fracture and is comparable
to forearm measurements for predicting fractures at other sites. Other
technologies for measuring peripheral sites include quantitative
ultrasonography (QUS), radiographic absorptiometry, single energy x-ray
absorptiometry, peripheral dual-energy x-ray absorptiometry, and peripheral
quantitative computed tomography. Recent data suggest that peripheral bone
density testing in the primary care setting can also identify postmenopausal
women who have a higher risk for fracture over the short term (1 year).
Further research is needed to determine the accuracy of peripheral bone
density testing in comparison with dual-energy x-ray absorptiometry (DXA). The
likelihood of being diagnosed with osteoporosis varies greatly depending on
the site and type of bone measurement test, the number of sites tested, the
brand of densitometer used, and the relevance of the reference range. - Estimates of the benefits of detecting and treating osteoporosis are based
largely on studies of bisphosphonates. Some women, however, may prefer other
treatment options (for example, hormone replacement therapy, selective
estrogen receptor modulators, or calcitonin) based on personal preferences or
risk factors. Clinicians should review with patients the relative benefits and
harms of available treatment options, and uncertainties about their efficacy
and safety, to facilitate an informed choice. - No studies have evaluated the optimal intervals for repeated screening.
Because of limitations in the precision of testing, a minimum of 2 years may
be needed to reliably measure a change in bone mineral density; however,
longer intervals may be adequate for repeated screening to identify new cases
of osteoporosis. Yield of repeated screening will be higher in older women,
those with lower BMD at baseline, and those with other risk factors for
fracture. - There are no data to determine the appropriate age to stop screening and
few data on osteoporosis treatment in women older than 85. Patients who
receive a diagnosis of osteoporosis fall outside the context of screening but
may require additional testing for diagnostic purposes or to monitor response
to treatment.
Scientific Evidence
Epidemiology and Clinical Consequences
One-half of all postmenopausal women will have an osteoporosis-related
fracture during their lives, including 25 percent who will develop a vertebral
deformity6
and 15 percent who will suffer a hip fracture.7
Risk for fracture increases steadily as bone density declines, with no
threshold. The commonly used definition of osteoporosis, derived from the World
Health Organization (WHO) recommendations for epidemiologic studies, defines a
BMD more than 2.5 standard deviations (SD) below the mean for a young healthy
adult woman as osteoporosis, and a BMD between 1 and 2.5 SD below the mean as
osteopenia. Based on the WHO criteria and DXA measurements at the femoral neck,
population-based studies estimate that 41 percent of white women older than 50
have osteopenia.8
When bone density is measured at the hip, spine, and wrist, 15 percent of white
women aged 50-59 and 70 percent of white women older than 80 have osteoporosis
by WHO criteria at at least one site.9
The prevalence of osteoporosis in Mexican-American women is similar to the
prevalence in white women. While rates of osteoporosis in African-American women
are approximately one-half those of the other groups, they are still substantial
(8 percent among women older than 50). Including all races, an estimated 14
million women older than 50 have osteopenia, and over 5 million have
osteoporosis.10
The actuarial risk of a 65-year-old white woman sustaining a fracture by age 90
is 16 percent for the hip, 9 percent for distal forearm, and 5 percent for
proximal humerus.9
Sixteen percent of postmenopausal women have osteoporosis of the lumbar
spine.11
Accuracy and Reliability of Screening Tests
The USPSTF examined two components of screening:
- The accuracy of risk factors or risk assessment instruments for
identifying women at risk for osteoporosis or fracture. - The accuracy of different bone density measurement techniques for
identifying women at risk for fracture who can benefit from osteoporosis
treatment.
Predicting Risk for Osteoporosis or Fracture
The USPSTF evaluated both individual risk factors and prescreening assessment
tools that incorporate two or more of the risk factors. Risk for osteoporosis
increases steadily and substantially with age. Relative to women aged 50-54, the
odds of having osteoporosis were 5.9-fold higher in women aged 65-69 and
14.3-fold higher in women aged 75-79, in a study of over 200,000 postmenopausal
women.12
Low body weight or body-mass index (BMI) and not using estrogen replacement were
also consistently associated with osteoporosis but to a lesser degree than age.
Other risk factors for fracture or low bone density found in some, but not all,
studies include white or Asian ethnicity, history of fracture, family history of
osteoporotic fracture, history of falls, low levels of physical activity,
smoking, excessive alcohol or caffeine use, low calcium or vitamin D intake, and
the use of various medications.
Specific instruments to assess risk for low bone density or fractures
generally have moderate-to-high sensitivity and low specificity. The best
validated instruments include the 3-item ORAI and the 6-item Simple Calculated
Osteoporosis Risk Estimation tool (SCORE). The ORAI uses age, weight, and
current use of hormone replacement therapy to identify women at risk for
osteoporosis and has a sensitivity of 94 percent and specificity of 41
percent.4
The SCORE has a sensitivity of 91 percent and specificity of 40 percent in one
validation population (n = 259), but it has much lower specificity in an older
population.11
Among eight studies of prediction instruments for fracture risk, most had
only modest sensitivity and specificity. The best performing model for hip
fracture outcomes included age, gender, height, use of a walking aid, current
smoking, and weight and had a sensitivity of 70 percent with specificity of 84
percent.13
Measurements of Bone Density
To date, bone density measured at the femoral neck by DXA is the best
predictor of hip fracture and is comparable to forearm measurements for
predicting fractures at other sites. Recent prospective studies have evaluated
QUS measurements at the heel.14,15
While QUS measurements are not highly correlated with DXA measurements, a result
in the osteoporotic range on either test is associated with an increased
short-term probability of hip fracture. Several other radiologic methods that
measure bone density at peripheral sites2
(including sites in the hand, heel, wrist, and forearm) include single photon
absorptiometry, quantitative computed tomography, single-energy x-ray
absorptiometry, and peripheral quantitative computed tomography.
In a study of over 200,000 women in a primary care setting, women diagnosed
with osteoporosis by peripheral bone density measurements were 4 times more
likely to have fractures than women with normal bone density over the subsequent
year. The likelihood of being diagnosed with osteoporosis varies greatly
depending on the site and type of bone measurement test, the number of sites
tested, the brand of densitometer, and the relevance of the reference range.
Effectiveness of Early Treatment
No controlled studies have evaluated the effect of screening on fractures or
fracture-related morbidity. The Task Force reviewed the evidence to determine
whether treatment for osteoporosis or low bone density in asymptomatic patients
reduced fractures.
Available trials that reported fracture outcomes have examined the efficacy
of bisphosphonates (alendronate and risendronate), estrogen, and selective
estrogen receptor modulators (raloxifene) and calcitonin. A meta-analysis16
of 11 randomized trials17-27
involving a total of 12,855 women, found that alendronate significantly reduced
vertebral fractures (RR, 0.52; 95 percent CI, 0.43-0.65), forearm fractures (RR,
0.48; 0.29-0.78), hip fractures (RR, 0.63; 0.43-0.92), and other nonvertebral
fractures (RR, 0.51; 0.38-0.69). There were nonsignificant trends toward
reduction in hip fractures. No randomized trial of treatment for osteoporosis
has demonstrated an impact on mortality. One trial in women aged 70-79 with very
low bone density (T-score less than -3) reported that risendronate reduced the
risk for hip fracture (RR, 0.60; 95 percent CI, 0.40-0.90).28
There are no direct comparisons of alendronate and estrogen or raloxifene
that report fracture outcomes. Estrogen, either alone or with progestin,
consistently improves bone density in randomized trials. The effects of estrogen
and the selective estrogen receptor modulators on fractures are reviewed in more
detail in a separate report.13
Only a few small randomized clinical trials of estrogen indicate mixed results
for fracture outcomes, but these studies are methodologically limited.
Observational studies report a 25-30 percent reduction in the risk for hip
fracture with estrogen use. A good-quality study of raloxifene reported a
reduced risk for vertebral fractures (RR, 0.59; 95 percent CI,
0.50-0.70).29
The benefits of treating osteoporosis are larger in women at higher risk for
fracture than in women at lower risk. The Fracture Intervention Trial (FIT) was
conducted with 2 different groups of participants: 2,027 high-risk women who had
T-scores of -1.6 or lower and pre-existing vertebral fractures, and 4,432 women
with comparable T-scores but no pre-existing vertebral fracture. Over 3 years of
treatment in high-risk women, alendronate reduced the risk for hip fracture (1.1
percent vs. 2.2 percent in the placebo group; relative hazard [RH], 0.49
[0.23-.099]) and the risk for any clinical fracture (18.2 percent vs. 13.6
percent; RH, 0.72 [0.58-0.90]). Among women with no pre-existing fracture, only
the subgroup of patients who had a T-score less than -2.5 had a significant
reduction in all clinical fractures from treatment, from 19.6 percent to 13.1
percent (RR, 0.64; 0.50-0.82). Alendronate had no effect on fractures among
lower risk women who had T-scores between -1.6 and -2.5.
These results suggest that treatment will produce larger benefits in women
with more risk factors for fracture, such as those who are older, have very low
bone density, or have pre-existing vertebral fractures. FIT, as well as other
therapy trials, enrolled highly selected patients thus limiting the
generalizability of their results to asymptomatic women detected in a typical
primary care setting.
There is little evidence regarding which patients are likely to benefit from
screening and treatment. It is not known whether women who have a similar
overall risk for fracture, but different bone densities, will benefit similarly
from treatment. This uncertainty is clinically important because the lack of
accepted criteria for initiating treatment remains a problem.
To estimate the benefits of routine screening for women in different age
groups, the USPSTF used estimates from recent studies to project the number of
fractures that would be prevented over 5 years from screening and treatment of a
hypothetical cohort of 10,000 postmenopausal women.2
For women aged 55-59, more than 4,000 would need to be screened to prevent 1 hip
fracture and more than 1,300 to prevent 1 vertebral fracture. For women older
than 60, the number needed to screen to prevent 1 hip fracture is 1,856 for
women aged 60-64, 731 for women aged 65-69, and 143 for women aged 75-79. The
benefits of screening improve substantially in older women because osteoporosis
is both more prevalent and more likely to lead to a fracture in older women.
In all age groups, the number needed to screen to prevent fractures is lower
in women with important risk factors than it is in women who do not have risk
factors. For women aged 60-64 who have a risk factor that increases the risk of
osteoporosis by 100 percent and fracture by 70 percent, the number needed to
screen is 1,092 and the number need to treat is 72 to prevent 1 hip fracture.
These numbers are comparable to those of women aged 65-69 without risk
factors.2
These estimates rely on many assumptions that may not apply for specific
populations.
Potential Adverse Effects of Screening and Treatment
There are several potential harms of screening, although the empirical data
for them are few. Women who undergo screening with bone density tests are more
likely to begin hormone replacement therapy than women who do not. However,
women who were diagnosed with osteoporosis after screening reported increased
fears and anxiety in one study. Other potential harms may arise from
inaccuracies and misinterpretations of bone density tests. Clinicians may have
difficulty in using test results to provide accurate information to the patients
because techniques used to measure bone density vary, test results are reported
as T-scores, and information on how to integrate bone density results with other
clinical predictors has not been clearly defined.2
In the alendronate treatment trials, gastrointestinal side effects occurred
in about 25 percent of patients taking alendronate, but this was usually not
higher (or only slightly higher) than the rate for placebo. Higher rates were
observed among Medicare enrollees taking alendronate. In the FIT-II trial, the
rates of ulcer disease were higher in the alendronate treatment group, with 2.2
percent developing ulcer disease, as opposed to 1.2 percent in the placebo group
(P<0.05).30
The long-term adverse effects of alendronate are unknown. Harms of hormone
replacement therapy include venous thromboembolic events, endometrial cancer,
and cholecystitis, all with relative risks of approximately 2.0.12
Both raloxifene and tamoxifen are associated with thromboembolic events, leg
cramps, and hot flashes.2
Recommendations of Others
In 1998, the National Osteoporosis Foundation, in collaboration with other
professional organizations, issued screening guidelines recommending bone
density testing for all women aged 65 or older and younger postmenopausal women
who have had a fracture or who have one or more risk factors for
osteoporosis.31
Collaborating groups included the American Academy of Orthopaedic Surgeons, the
American College of Obstetricians and Gynecologists, the American Geriatrics
Society, the American College of Radiology, the American College of
Rheumatology, the American Academy of Physical Medicine and Rehabilitation, the
American Association of Clinical Endocrinologists, the Endocrine Society, and
the American Society of Bone and Mineral Research. The American Association of
Clinical Endocrinologists released revised guidelines in 2001.32
A 2000 Consensus Development Conference sponsored by the U.S. National
Institutes of Health concluded that the value of universal osteoporosis
screening was not yet established.33
The conference panel recommended an individualized approach to screening, noting
that bone density measurement is appropriate when it will aid the patient’s
decision to institute treatment. The Canadian Task Force on Preventive Health
Care is currently revising its recommendations on screening for osteoporosis.
Appendix A. USPSTF Recommendations and Ratings
The USPSTF grades its recommendations according to one of five
classifications (A, B, C, D, or I), reflecting the strength of evidence and
magnitude of net benefit (benefits minus harms):
A. The USPSTF strongly recommends that clinicians routinely provide
[the service] to eligible patients. The USPSTF found good evidence that [the
service] improves important health outcomes and concludes that benefits
substantially outweigh harms.
B. The USPSTF recommends that clinicians routinely
provide [the service] to eligible patients. The USPSTF found at least fair
evidence that [the service] improves important health outcomes and concludes
that benefits outweigh harms.
C. The USPSTF makes no recommendation for or against
routine provision of [the service]. The USPSTF found at least fair evidence
that [the service] can improve health outcomes but concludes that the balance of
benefits and harms is too close to justify a general recommendation.
D. The USPSTF recommends against routinely providing [the service] to
asymptomatic patients. The USPSTF found at least fair evidence that [the
service] is ineffective or that harms outweigh benefits.
I. The USPSTF concludes that the evidence is insufficient to recommend
for or against routinely providing [the service]. Evidence that [the service]
is effective is lacking, of poor quality, or conflicting and the balance of
benefits and harms cannot be determined.
Appendix B. USPSTF Strength of Overall Evidence
The USPSTF grades the quality of the overall evidence for a service on a
3-point scale (good, fair, or poor):
Good: Evidence includes consistent results from well-designed,
well-conducted studies in representative populations that directly assess
effects on health outcomes.
Fair: Evidence is sufficient to determine effects on health outcomes,
but the strength of the evidence is limited by the number, quality, or
consistency of the individual studies; generalizability to routine practice; or
indirect nature of the evidence on health outcomes.
Poor: Evidence is insufficient to assess the effects on health
outcomes because of limited number or power of studies, important flaws in their
design or conduct, gaps in the chain of evidence, or lack of information on
important health outcomes.
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Acknowledgments
Members of the U.S. Preventive Services Task Force are Alfred O. Berg, M.D.,
M.P.H., Chair, USPSTF (Professor and Chair, Department of Family Medicine,
University of Washington, Seattle, WA); Janet D. Allan, Ph.D., R.N., C.S.,
F.A.A.N., Vice-chair, USPSTF (Dean, School of Nursing, University of Maryland
Baltimore, Baltimore, M.D.); Paul Frame, M.D. (Tri-County Family Medicine,
Cohocton, NY, and Clinical Professor of Family Medicine, University of
Rochester, Rochester, NY); Charles J. Homer, M.D., M.P.H. (Executive Director,
National Initiative for Children’s Healthcare Quality, Boston, MA); Mark S.
Johnson, M.D., M.P.H. (Chair, Department of Family Medicine, University of
Medicine and Dentistry of New Jersey-New Jersey Medical School, Newark, NJ);
Jonathan D. Klein, M.D., M.P.H. (Associate Professor, Department of Pediatrics,
University of Rochester School of Medicine, Rochester, NY); Tracy A. Lieu, M.D.,
M.P.H. (Associate Professor, Department of Ambulatory Care and Prevention,
Harvard Pilgrim Health Care and Harvard Medical School, Boston, MA); Cynthia D.
Mulrow, M.D., M.Sc. (Clinical Professor and Director, Department of Medicine,
University of Texas Health Science Center, and Director, National Program Office
for Robert Wood Johnson Generalist Physician Faculty Scholars Program, San
Antonio, TX); C. Tracy Orleans, Ph.D. (Senior Scientist and Senior Program
Officer, The Robert Wood Johnson Foundation, Princeton, NJ); Jeffrey F. Peipert,
M.D., M.P.H. (Director of Research, Women and Infants’ Hospital, Providence,
RI), Nola J. Pender, Ph.D., R.N., F.A.A.N. (Professor Emeritus, University of
Michigan, Ann Arbor, MI); Albert L. Siu, M.D., M.S.P.H. (Professor of Medicine,
Chief of Division of General Internal Medicine, Mount Sinai School of Medicine,
New York, NY); Steven M. Teutsch, M.D., M.P.H. (Senior Director, Outcomes
Research and Management, Merck & Company, Inc., West Point, PA); Carolyn
Westhoff, M.D., M.Sc. (Professor of Obstetrics and Gynecology and Professor of
Public Health, Columbia University, New York, NY); and Steven H. Woolf, M.D.,
M.P.H. (Professor, Department of Family Practice and Department of Preventive
and Community Medicine and Director of Research, Department of Family Practice,
Virginia Commonwealth University, Fairfax, VA).
Reprints
Available online through the National Guideline Clearinghouse™ (http://www.guideline.gov/); reprints can be
obtained from the AHRQ Publications Clearinghouse (call 1-800-358-9295; E-mail
).
Current as of September 2002
Internet Citation:
U.S. Preventive Services Task Force. Screening for
Osteoporosis in Postmenopausal Women. September 2002. Originally in
Annals of Internal Medicine 2002;137:526-8. Agency for Healthcare
Research and Quality, Rockville, MD.
http://www.ahrq.gov/clinic/3rduspstf/osteoporosis/osteorr.htm
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