Anti-vertebral fracture efficacy of raloxifene: a meta-analysis.

In the Multiple Outcomes of Raloxifene Evaluation (MORE) trial, raloxifene reduced the risk of vertebral fracture. However, a systematic analysis of the anti-vertebral fracture efficacy of raloxifene, which includes the results of newly reported studies, has not been performed. A meta-analysis was carried out using all randomized, double-blind, placebo-controlled trials to determine whether the reduction in the risk for vertebral fracture, reported with raloxifene, was consistent among studies, and to define more accurately the point estimate of the odds ratio. Three prevention studies, two arms of the MORE trial, and three additional treatment studies in which fracture data were available from prospectively scheduled spinal radiographs were included in the analysis. A systematic review of the literature (MedLine, EMBASE) confirmed that no studies with raloxifene had been excluded from this analysis. The effects of raloxifene 60 mg/day (RLX60) and 120 mg/day pooled with 150 mg/day (RLX120/150) were analyzed by intention to treat. There was no significant heterogeneity among the studies included in the meta-analysis. Odds ratio estimates (95% CI) were 0.60 (0.49, 0.74) for RLX60 and 0.51 (0.41, 0.64) for RLX120/150. From these data we infer that raloxifene consistently reduces the risk of vertebral fracture in postmenopausal women.