Effect of Alendronate on Vertebral Fracture Risk in Women With Bone Mineral Density T Scores of −1.6 to −2.5 at the Femoral Neck: The Fracture Intervention Trial

Department of Medicine, University of California, San Diego, San Diego, California, United States
Mayo Clinic Proceedings (Impact Factor: 6.26). 04/2005; 80(3):343-9. DOI: 10.4065/80.3.343
Source: PubMed


To determine the efficacy of alendronate treatment on risk of vertebral fracture in a subgroup of women from the Fracture Intervention Trial who had bone mineral density T scores between -1.6 and -2.5 at the femoral neck and to describe how soon after initiation of therapy alendronate becomes effective and whether it is consistent in women with and without existing radiographic vertebral fracture.
From May 1992 to March 1997, postmenopausal women aged 55 to 80 years were randomized to receive alendronate at 5 mg/d for 2 years and 10 mg/d thereafter or placebo for up to 4.5 years (mean, 3.8 years) in a controlled, double-blind, multicenter study.
A total of 3737 postmenopausal women were included in the study, 1878 in the alendronate group and 1859 in the placebo group. Risk of vertebral fracture was significantly reduced by alendronate compared with placebo for clinical (relative risk [RR], 0.40; 95% confidence interval [CI], 0.19-0.76; P=.005) and radiographic (RR, 0.57; 95% CI, 0.41-0.81; P=-.002) fracture. The reductions in vertebral fracture risk were consistent in women with and without an existing radiographic vertebral fracture for clinical (RR, 0.34; 95% CI, 0.12-0.84; and RR, 0.46; 95% CI, 0.16-1.17; respectively) and radiographic (RR, 0.53; 95% CI, 0.34-0.82; and RR, 0.64; 95% CI, 0.38-1.10; respectively) fractures. In both groups, the effect of alendronate on clinical vertebral fracture was noted soon after therapy was initiated. The absolute risk of vertebral fracture was low in women without a baseline radiographic fracture.
In women with low bone mass who do not meet the bone mineral density criterion for osteoporosis, alendronate is effective in reducing the risk of vertebral fractures. The absolute benefit of this therapy in women with a T score between -1.6 and -2.5 is greater in women with an existing vertebral fracture and/or with other risk factors. The effect of alendronate occurs early.

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    • "A lot of these discussions have centered around estimates of numbers needed to treat (NNT). While the most effective antiresorptive treatment today have NNT values for prevention of one fracture around 13–15 for spine fractures similar numbers in osteopenia patients are 8–10 fold higher [4, 5]. As shown in the analysis of Quandt et al. [4] the presence of a prevalent fracture yields a NNT for subsequent fracture over the next 5 years of 26, compared to 125 in patients without fractures at entry into the study. "
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    ABSTRACT: The majority of osteoporotic fractures happen in individuals with BMD t-scores in the osteopenic range (-2,5< t-score <-1). However, widespread use of anti-osteoporotic medication in this group based on t-score alone is not advisable because: 1) the number needed to treat is much higher (NNT>100) than in patients with fractured and t-score below -2,5 (NNT 10-20); 2)while specific osteoporosis treatments have demonstrated significant reductions of the fracture risk in patients with t-score <-2, 5, the efficacy in patients in the osteopenic range is less well established. Therefore, an osteopenic t-score does not in itself constitute a treatment imperative. Generally, osteopenia has to be associated with either low energy fracture(s) or very high risk for future fracture as assessed with risk calculators like FRAX to warrant specific osteoporosis therapy. Vertebral fractures are now conveniently assessed using lateral x-rays from DXA machines. In the vast majority of cases antiresorptive treatments (mainly hormone replacement therapy and SERMS in younger and bisphosphonates or Denosumab in older women) are the treatments of choice in this group of patients,-only rarely is anabolic therapy indicated.
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    • "Fracture reduction efficacy for subgroups of women with T-scores in the osteopenic range have been reported for both raloxifene[23] and alendronate[24]. While there is disagreement about whether alendronate reduces risk of vertebral fracture in osteopenic women [24-27], we assumed that the vertebral fracture risk reduction with alendronate that was reported for women with osteoporosis[25] also applied to women with osteopenia. Neither therapy has demonstrated efficacy in preventing nonvertebral fractures in osteopenic women [23-25]. "
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