Efficacy of Bazedoxifene in Reducing New Vertebral Fracture Risk in Postmenopausal Women With Osteoporosis: Results From a 3-Year, Randomized, Placebo-, and Active-Controlled Clinical Trial

• DOI: 10.1359/jbmr.080710
• Publication Date: 2008-07-29T15:26:50Z
• Authors: Stuart L Silverman; Claus Christiansen; Harry K Genant; Slobodan Vukicevic; José R Zanchetta; Tobie J de Villiers; Ginger D Constantine; Arkadi A Chines
• Keywords: Raloxifene; Clinical endpoint

Abstract In this 3-yr, randomized, double-blind, placebo- and active-controlled study, healthy postmenopausal women with osteoporosis (55–85 yr of age) were treated bazedoxifene 20 or 40 mg/d, raloxifene 60 placebo. The primary endpoint was incidence new vertebral fractures after 36 mo; secondary endpoints included nonvertebral fractures, BMD, bone turnover markers. Among 6847 subjects in the intent-to-treat population, significantly lower (p < 0.05) mg (2.3%), (2.5%), (2.3%) compared placebo (4.1%), relative risk reductions 42%, 37%, respectively. treatment effect similar among without prevalent fracture = 0.89 for by baseline status interaction). not different from a posthoc analysis subgroup at higher (femoral neck T-score ≤ –3.0 and/or ≥1 moderate severe multiple mild fractures; n 1772), showed 50% 44% reduction to 0.02) 0.05), Bazedoxifene improved BMD reduced marker levels 0.001 versus placebo). vasodilatation, leg cramps, venous thromboembolic events conclusion, decreased risk.