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Introduction

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

Screening is the early diagnosis of presymptomatic disease among well individuals in the general population.1 The purpose of osteoporosis screening using bone mineral density (BMD) testing by dual energy X-ray absorptiometry (DXA) is to identify a presymptomatic condition (osteoporosis as defined by World Health Organization diagnostic criteria) that can be treated to prevent an adverse clinical outcome (fragility fractures). An osteoporosis screening program primarily targets the prevention of hip and clinical vertebral fractures because these fractures are associated with the majority of morbidity and health care utilization attributable to osteoporotic fractures. The U.S. Preventive Services Task Force2 (USPSTF) assigned osteoporosis screening an evidence grade B based on findings from prospective cohort studies of DXA testing and results of randomized controlled trials (RCTs) demonstrating that pharmacologic therapy in postmenopausal women with osteoporosis3–6 reduced the incidence of fractures. Until recently, prospective data regarding an osteoporosis screening interval were lacking,7 and several organizations8–13 recommended BMD screening intervals of about 2 to 5 years based on expert opinion.

Gourlay and Colleagues' Study of BMD Screening Intervals

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

The study by Gourlay and colleagues14 used data collected in the Study of Osteoporotic Fractures (SOF) to estimate the time to osteoporosis before occurrence of hip or clinical vertebral fracture and before initiation of pharmacologic therapy for osteoporosis. The purpose of this study was to help inform primary care providers about the length of osteoporosis screening intervals for older women without osteoporosis at baseline. Our study addressed the frequency of repeated testing, not ordering of an initial BMD test. We strongly concur with Lewiecki and colleagues15 that too few initial BMD tests are performed in older women.16 With respect to the frequency of repeat testing, our study's reported time estimates will assist primary care providers in tailoring the BMD screening interval in older female patients according to initial BMD T-score and age. Based on the results of our study, clinicians might order fewer tests in lower-risk patients (eg, those with BMD T-score above −1.5) and more frequent tests in higher-risk patients (eg, those with BMD T-score −1.5 and below). Other factors, such as DXA reimbursement policies, will also impact ordering of initial and repeat BMD testing in clinical practice.

Generalizability of Results

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

Our study results are generalizable to the large and growing population of Medicare-aged women for whom guidelines2, 8–13 universally encourage consideration of osteoporosis screening by primary care physicians. In the United States alone, according to 2009 U.S. Census figures, over 22 million women are aged 65 years and older.17 Women who were not candidates for osteoporosis screening were excluded from our analysis, including women with osteoporosis at baseline or those with a prior history of hip or clinical vertebral fracture, because these women are already candidates for pharmaceutical treatment. Our results also do not apply to patients already receiving pharmacologic treatments, for whom the utility of BMD monitoring remains controversial.18 Finally, our results are not generalizable to patients with secondary causes of osteoporosis who are receiving DXA testing for disease or medication management (eg, patients with rheumatoid arthritis taking chronic oral glucocorticoids).

The SOF enrolled older African American women beginning with the Year 10 examination in 1997–1998. However, Gourlay and colleagues'14 analysis was restricted to SOF participants (99.7% white) enrolled at the baseline examination in 1986–1988 because only these women had a sufficient number of serial BMD measurements for calculation of time intervals. The rate of loss in BMD at the hip after age 65 years is significantly higher for white women compared to nonwhite women.19 Thus, the estimated screening intervals reported for white women in the SOF are shorter than the expected intervals for nonwhite older women. It is very unlikely that policymakers would recommend modification of BMD screening intervals according to race or ethnic group. We expect that most clinicians will choose to be conservative by applying the shorter screening intervals for white women to all women irrespective of race or ethnicity.

We agree that our results should not be generalized to postmenopausal women under age 65 years or to older men. To our knowledge, no previous study has estimated time to transition to osteoporosis in postmenopausal women aged 50 to 64 years at baseline. Extrapolation of the more rapid rates of spine BMD loss occurring during and immediately after the menopausal transition would lead to inappropriately short screening intervals for postmenopausal women in this age group who have a low prevalence of osteoporosis (4% of U.S. women aged 50–59 years according to estimates from the National Health and Nutrition Examination Survey III, 1988–9420) and low incidence of fragility fracture compared to older women. Burge and colleagues21 reported that the female population aged 65 years and older bears 89% of the total cost of incident fractures in women, especially women 75 years and older. In the absence of relevant data, recommendations about initial BMD testing and the frequency of BMD testing in younger women should consider their lower risk of osteoporosis and fragility fracture, and their greater risk of potential harms from long-term pharmacologic treatment that could exceed 30 years over their remaining lifetime. There is also a critical need for data to inform recommendations about repeat BMD testing intervals in older men.

Role of Clinical Risk Factors

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

Our results take into account both increased rates of bone loss with advancing age and several clinical risk factors for fracture, including history of prior fracture. Our findings underscore that BMD testing intervals for women after the initial test must account for bone loss with increasing age; ie, the BMD screening interval should be readdressed with each new test result. For example, a woman with a BMD T-score of −1.20 at age 70 might have a T-score of −1.70 on a DXA test 15 years later (at age 85 years). Using a literal interpretation of our time-to-osteoporosis estimates, this patient's next DXA test would be in 3 years (Table 3 in Gourlay and colleagues14), not 15 years. Prior studies have suggested that the rate of change in BMD as measured by DXA is an independent predictor of subsequent fracture risk, but is a weaker predictor than initial BMD.22–24 This is consistent with our study findings and indicates that the current BMD T-scores can be used to estimate a screening interval. Importantly, adjustment for several clinical risk factors, including six factors in the WHO Fracture Risk Assessment Tool (FRAX) model (http://www.shef.ac.uk/FRAX), had minimal effect on our estimates of time to transition to osteoporosis as a whole, but a significant trend for age did support shorter testing intervals with advancing age of the patient. Our findings suggesting that initial BMD value is the most important determinant of the screening interval decision are supported by results of other prospective studies.24, 25

Lumbar Spine BMD

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

In our primary analysis, we used T-scores calculated from both femoral neck and total hip BMD because this led to more stable time estimates than using femoral neck BMD alone in women with normal BMD at baseline (main manuscript Table 2 versus Supplementary Appendix Table D in Gourlay and colleagues14). As is true of the FRAX tool, the T-score calculations in our models did not include lumbar spine BMD. As part of clinical decision making, clinicians considering our results might choose a shorter osteoporosis screening interval for patients who have lower T-scores at the spine compared to the hip.

Epidemiological Standards for Evidence on Osteoporosis Screening

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

Every study of screening must be judged against epidemiological standards for screening programs. This evaluation includes consideration of the validity of the screening test itself, feasibility of the program, and whether its implementation actually achieves a reduction in morbidity and mortality from the disease.1, 26, 27 Ideally, this is accomplished in an RCT; however, multiple, large, well-conducted observational studies with consistent results may be judged sufficient to determine the magnitude of benefits and harms of screening.28 The essential outcomes in prospective studies of screening are health outcomes (symptoms and conditions that patients can feel or experience, eg, hip and clinical vertebral fractures), not intermediate outcomes (eg, abnormal laboratory tests or fracture risk assessment tool scores) or clinically silent conditions. The fact that screening has a proven effect on an intermediate outcome does not necessarily establish that it can improve outcomes that are perceptible to patients.28 These standards for high-quality evidence on screening raise concerns about Lewiecki and colleagues'15 comments regarding two key issues:

  • 1.
    Fracture risk estimates as a potential intermediate outcome. We chose osteoporosis by BMD criteria as the primary outcome in our study because DXA BMD testing has been evaluated prospectively in multiple cohort studies29–32 that used clinical fracture outcomes, because numerous randomized trials 3–6 have demonstrated the benefit of pharmacologic treatment in postmenopausal women selected on the basis of osteoporosis as defined by BMD criteria, and because the USPSTF2, 33 has rigorously reviewed these data to assess the magnitude of benefits, harms, and net benefit of the use of DXA BMD testing in postmenopausal women. Because the most important targets for prevention in this screening program are the health outcomes of hip and clinical vertebral fractures, we also conducted an analysis to estimate the time for 2% of older women in four T-score groups > −2.5 at baseline to experience a hip or clinical vertebral fracture before development of osteoporosis or initiation of pharmacologic treatment (Supplementary Appendix, Table F in Gourlay and colleagues14). These time estimates were approximately the same or longer than the time estimates for 10% of women to develop osteoporosis in the main analysis, even after adjustment for clinical risk factors. We concluded that with the use of the stated criteria for the study, consideration of the time to a hip or clinical vertebral fracture would not substantially alter recommendations for osteoporosis screening intervals based on the time to osteoporosis alone.
    FRAX and other fracture risk prediction calculators play an important role in clinical practice, but they have not been evaluated prospectively for use in screening. Lewiecki and colleagues15 asserted that “the [Gourlay and colleagues] study did not capture those patients with osteopenia who by the FRAX fracture risk assessment would have been at high risk for fracture and therefore warrant drug therapy.” Such an approach using an intermediate outcome of FRAX treatment cut points recommended for use in the United States9 would have guaranteed shorter estimated times for 10% of the older women to transition to “high” fracture risk.34–36 Before considering this strategy based on an intermediate outcome, prospective evidence is needed to demonstrate that pharmacologic treatment reduces clinical fractures in a population selected on the basis of BMD T-score above −2.5 and FRAX scores at or above treatment thresholds.
  • 2.
    Radiographic vertebral fracture as an intermediate outcome. Like the FRAX model, our models did not include incident radiographic vertebral fractures as an outcome for several reasons. The vast majority of these deformities are asymptomatic, and their clinical significance is controversial (other than for risk prediction).37 Whereas “silent” radiographic deformities are associated with an increased risk of back-related pain and disability, the strength of these associations is much greater among persons with clinical vertebral fractures.38 Finally, information about radiographic deformity status as identified using DXA is not currently available to the majority of primary care providers in making treatment decisions.

Conclusions

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

Osteoporosis screening research is far behind other screening programs in the quantity and quality of evidence that directly tests screening strategies. Development of an evidence-based osteoporosis screening protocol depends on continued rigorous prospective studies of DXA BMD testing with a focus on the prevention of hip and clinical vertebral fractures. Despite consistent evidence supporting the use of DXA BMD screening in all women aged 65 years and older, many patients in this group never receive BMD testing. Thus, based on available data, including that from our study of testing intervals, efforts should be undertaken to promote increased rates of first DXA tests for women aged 65 years and older, and the frequency of subsequent testing among women without identification of osteoporosis on their initial test should be tailored according to the patient's current T-scores and age.

Acknowledgements

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information

The project described was funded by grant number K23RR024685 from the National Center for Research Resources. The Study of Osteoporotic Fractures (SOF) is supported by the National Institutes of Health (Public Health Service research grants AG05407, AR35582, AG05394, AR35584, AR35583, R01 AG005407, R01 AG027576-22, 2 R01 AG005394-22A1, and 2 R01 AG027574-22A1). The content is solely the responsibility of the authors and does not necessarily reflect the official views of the funding agencies.

References

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information
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Supporting Information

  1. Top of page
  2. Introduction
  3. Gourlay and Colleagues' Study of BMD Screening Intervals
  4. Generalizability of Results
  5. Role of Clinical Risk Factors
  6. Lumbar Spine BMD
  7. Epidemiological Standards for Evidence on Osteoporosis Screening
  8. Conclusions
  9. Disclosures
  10. Acknowledgements
  11. References
  12. Supporting Information
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jbmr_1585_sm_chinese_translation.pdf466KSupplementary Information: Chinese Translation

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