Fracture risk reduction with alendronate in women with osteoporosis: the Fracture Intervention Trial

We examined the effect of alendronate treatment for 3–4 yr on risk of new fracture among 3658 women with osteoporosis enrolled in the Fracture Intervention Trial. This cohort included women with exist-ing vertebral fracture and those with osteoporosis as defined by T score of less than 22.5 at the femoral neck but without vertebral fracture. All analyses were prespecified in the data analysis plan. The magnitudes of reduction of fracture incidence with alendro-nate were similar in both groups. The two groups were, therefore, pooled to obtain a more precise estimate of the effect of alendronate on relative risk of fracture (relative risk, 95 % confidence interval): hip (0.47, 0.26–0.79), radiographic vertebral (0.52, 0.42–0.66), clinical vertebral (0.55, 0.36–0.82), and all clinical fractures (0.70, 0.59– 0.82). Reductions in risk of clinical fracture were statistically signif-icant by 12 months into the trial