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Does a History of Non-Vertebral Fracture Identify Women Without Osteoporosis for Treatment?

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Abstract

Background

Postmenopausal women with a prior fracture have an increased risk for future fracture. Whether a history of non-vertebral fracture defines a group of women with low bone mass but without osteoporosis for whom alendronate would prevent new non-vertebral fracture is not known.

Subjects and Methods

Secondary analysis of data from the Fracture Intervention Trial (FIT). Of 2,785 postmenopausal women with a T-score at the femoral neck between −1 and −2.5 and without prevalent radiographic vertebral deformity, 880 (31.6%) reported experiencing a fracture after 45 years of age. Women were randomized to placebo or alendronate (5 mg/day years for the first 2 years and 10 mg/day thereafter) and were followed for an average of 4.2 ± 0.5 years. Incident non-vertebral fractures were confirmed by x-rays and radiology reports.

Results

In the placebo arm, a self-report of prior fracture identified women with a 1.5-fold (hazard ratio [RH] 1.46, 95% C.I. 1.04–2.04) increased risk for incident non-vertebral fracture. However, there was no evidence that the effect of alendronate differed across subgroups of women with (RH 1.26 for alendronate vs placebo, 95% C.I. 0.89–1.79) and without prior fracture (RH 1.02 for alendronate vs placebo, 95% C.I. 0.76–1.38; P = 0.37 for interaction).

Conclusion

Assessing a clinical risk factor, prior non-vertebral fracture, did not identify women with low bone mass for whom alendronate reduced future non-vertebral fracture risk.

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Acknowledgments

This research was sponsored by Merck Research Laboratories, Rahway, NJ.

Members of the Fracture Intervention Trial Research Group are listed in reference 23.

Authors’ contributions

Conception: KMR, SRC; Design: KMR, SRC, DCB, SS; analysis and interpretation: LP, KMR, SRC, DCB, KE; manuscript preparation: KMR, LP, SS, SRC, DCB, AF, JS, KE, AVS SRC

Sponsor role

Drafts of the manuscript were reviewed, and changes to the manuscript were recommended by all coauthors and staff at Merck. The final version of this manuscript was reviewed by all coauthors and the Fracture Intervention Trial Steering Committee; Merck Investigators constituted a minority of the steering committee. Merck Research Laboratories funded the original FIT study.

Lisa Palermo had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Conflict of Interest statement

KMR: prior research grant support from Eli Lilly; past speaker support from Proctor & Gamble. SRC: none; LP: none; SS: research grant support from Wyeth Pharmaceuticals; DCB: research funding from Merck Research Laboratories, Proctor and Gamble, Amgen, and Smith Kline Beecham; ACF: research grant support from Merck Research Laboratories, Amgen and Sanofi-Aventis; JTS: none; AVS: none; KE: none.

Author information

Authors and Affiliations

  1. The Department of Medicine, The University of Tennessee Health Science Center, Memphis, TN, USA

    Suzanne Satterfield MD, DrPH

  2. Department of Preventive Medicine, The University of Tennessee Health Science Center, Memphis, TN, USA

    Kathryn M. Ryder MD, MS & Suzanne Satterfield MD, DrPH

  3. The Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA, USA

    Steven R. Cummings MD, Lisa Palermo MS, Douglas C. Bauer MD & Ann V. Schwartz PhD

  4. The Department of Medicine, University of California, San Francisco, San Francisco, CA, USA

    Douglas C. Bauer MD

  5. The Center for Health Research, Kaiser Permanente Northwest, Portland, OR, USA

    Adrianne C. Feldstein MD, MS

  6. Division of Health Policy and Management, University of Minnesota, The Park Nicollet Health Services, Minneapolis, MN, USA

    John T. Schousboe MD, MS

  7. The Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs Medical Center, University of Minnesota, Minneapolis, MN, USA

    Kristine Ensrud MD, MPH

  8. Department of Medicine and Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA

    Kristine Ensrud MD, MPH

  9. Division of General Internal Medicine, Department of Medicine, Memphis, TN, USA

    Kathryn M. Ryder MD, MS

Authors
  1. Kathryn M. Ryder MD, MS
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  2. Steven R. Cummings MD
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  3. Lisa Palermo MS
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  4. Suzanne Satterfield MD, DrPH
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  5. Douglas C. Bauer MD
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  6. Adrianne C. Feldstein MD, MS
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  7. John T. Schousboe MD, MS
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  8. Ann V. Schwartz PhD
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  9. Kristine Ensrud MD, MPH
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for the Fracture Intervention Trial Research Group

Corresponding author

Correspondence to Kathryn M. Ryder MD, MS.

Additional information

This work is supported by K23 RR16047 and Merck Research Laboratories, Rahway, NJ.

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Ryder, K.M., Cummings, S.R., Palermo, L. et al. Does a History of Non-Vertebral Fracture Identify Women Without Osteoporosis for Treatment?. J GEN INTERN MED 23, 1177–1181 (2008). https://doi.org/10.1007/s11606-008-0622-0

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  • DOI: https://doi.org/10.1007/s11606-008-0622-0

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