Effects of long-term use and discontinuation of alendronate have been reported previously, but it is not known if BMD achieved after several years of alendronate (ALN) use is associated with subsequent BMD changes during continued ALN use. To address this issue, we examined change in total hip BMD during the 5-year FIT Long-term EXtension (FLEX) Study.
Women previously randomized to ALN in the Fracture Intervention Trial (FIT) were re-randomized to placebo (40%) or ALN 5 (30%) or 10 (30%) mg/d for an additional 5 years. All women had low hip BMD at FIT baseline. Their average use of ALN prior to randomization into FLEX was five years. Tertiles of BMD at the total hip, measured at FLEX baseline, corresponded to <0.690, 0.690 to <0.769, and ³0.769 g/cm2. At least one follow-up BMD measurement was available on 1,071 (97%) of the 1,099 women randomized to FLEX. Differences between pooled ALN and placebo groups at 60 months were evaluated.
Among women in the lowest tertile of FLEX baseline BMD, those on placebo lost 2.23% (95% CI: 1.02, 3.43) more total hip BMD than those who continued ALN. The difference for women in the middle tertile was 2.56% (95% CI: 1.75, 3.38), and the difference for the highest tertile of baseline BMD was 2.04% (95% CI: 1.21, 2.87). In women who used ALN for an average of 5 years, continued ALN use for an additional 5 years preserved bone relative to discontinuation in all three levels of baseline BMD. The effect of continued alendronate use on BMD was similar for different levels of baseline BMD achieved after previous alendronate use.
Disclosure Information:
Faculty Member's Name: A.V. Schwartz, PhD
Grants/Research Support: Merck & Co., Inc.
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