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Use of Alendronate After 5 Years of Treatment—Reply
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In Reply: In response to Drs Erviti and Gorricho, FLEX was designed to compare continuing or discontinuing alendronate after 5 years. The study did not include a long-term placebo group because it was no longer ethical to continue placebo. This lack of a comparison group with no exposure to alendronate is a limitation of our study for both efficacy and safety analyses. One of the hypothesized safety concerns with long-term bisphosphonate use is that prolonged bone turnover suppression might decrease bone strength. We believe that this is unlikely given our fracture results, the initial FIT results showing fracture reductions with alendronate vs placebo over 4 years,1-3 and nonvertebral fracture rates in FLEX being consistent with projected rates from the FIT alendronate group. Also, the histomorphometry substudy, while very small, was consistent with normal bone remodeling.
We found no fracture rate differences between patients who had initially taken 5 mg/d vs . . . [Full Text of this Article]
Dennis M. Black, PhD
dblack@psg.ucsf.edu
Ann V. Schwartz, PhD
Department of Epidemiology and Biostatistics
University of California
San Francisco
Steven R. Cummings, MD
California Pacific Medical Center Research Institute
San Francisco
Jane A. Cauley, DrPH
Department of Epidemiology
University of Pittsburgh
Pittsburgh, Pa
Lisa Palermo, MA
Department of Epidemiology and Biostatistics
University of California
San Francisco
for the FLEX Research Group
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RELATED ARTICLE
Effect of Alendronate on Risk of Fracture in Women With Low Bone Density but Without Vertebral Fractures: Results From the Fracture Intervention Trial
Steven R. Cummings, Dennis M. Black, Desmond E. Thompson, William B. Applegate, Elizabeth Barrett-Connor, Thomas A. Musliner, Lisa Palermo, Ronald Prineas, Susan M. Rubin, Jean C. Scott, Thomas Vogt, Robert Wallace, A. John Yates, Andrea Z. LaCroix, and for the Fracture Intervention Trial Research Group
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