Objectives To determine the effectiveness of alendronate in reducing the risk of clinical vertebral fractures (CVFX) in women with osteopenia who do not meet the BMD criterion for osteoporosis.
Methods We studied 3737 women, age 55 to 80, from the Fracture Intervention Trial who had BMD T-score > -2.5 at the femoral neck: 940 with an existing morphometric vertebral fracture (MVFX) and 2797 without. 1859 were treated with PBO and 1878 were treated with ALN 5 mg per day for the first two years and 10 mg for the remaining period for up to 2.5 years. All CVFX were confirmed by a physician.
Results The absolute risk of CFVX was about 4 to 5 fold greater in women with existing MVFX than in those without. Alendronate significantly (p = 0.005) reduced the overall risk of CFVX by 60% (RR = 0.40 (0.19, 0.76)). The reductions were consistent among those with and without MVFX: 0.34 (0.12, 0.84) and 0.46 (0.16, 1.17) respectively. The effect was observed very early. There were no CFVX in the first year among the alendronate patients.
Conclusion Alendronate was equally effective in reducing the relative risk of painful clinical vertebral fractures in women with and without existing MVFX. The effect of alendronate was seen early.
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