Dr Silverman has served on advisory boards for Wyeth and Lilly and on the speakers bureau for Lilly.
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†
Article first published online: 28 JUL 2008
Copyright © 2008 ASBMR
Journal of Bone and Mineral Research
Volume 23, Issue 12, pages 1923–1934, December 2008
How to Cite
Silverman, S. L., Christiansen, C., Genant, H. K., Vukicevic, S., Zanchetta, J. R., de Villiers, T. J., Constantine, G. D. and Chines, A. A. (2008), 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. J Bone Miner Res, 23: 1923–1934. doi: 10.1359/jbmr.080710
These results were presented at the 29th Annual Meeting of the American Society for Bone and Mineral Research, September 16–19, 2007, Honolulu, HI, USA.
- Issue published online: 4 DEC 2009
- Article first published online: 28 JUL 2008
- Manuscript Accepted: 25 JUL 2008
- Manuscript Revised: 19 JUN 2008
- Manuscript Received: 18 MAR 2008
- selective estrogen receptor modulator;
- fracture risk
In this 3-yr, randomized, double-blind, placebo- and active-controlled study, healthy postmenopausal women with osteoporosis (55–85 yr of age) were treated with bazedoxifene 20 or 40 mg/d, raloxifene 60 mg/d, or placebo. The primary endpoint was incidence of new vertebral fractures after 36 mo; secondary endpoints included nonvertebral fractures, BMD, and bone turnover markers. Among 6847 subjects in the intent-to-treat population, the incidence of new vertebral fractures was significantly lower (p < 0.05) with bazedoxifene 20 mg (2.3%), bazedoxifene 40 mg (2.5%), and raloxifene 60 mg (2.3%) compared with placebo (4.1%), with relative risk reductions of 42%, 37%, and 42%, respectively. The treatment effect was similar among subjects with or without prevalent vertebral fracture (p = 0.89 for treatment by baseline fracture status interaction). The incidence of nonvertebral fractures with bazedoxifene or raloxifene was not significantly different from placebo. In a posthoc analysis of a subgroup of women at higher fracture risk (femoral neck T-score ≤ –3.0 and/or ≥1 moderate or severe vertebral fracture or multiple mild vertebral fractures; n = 1772), bazedoxifene 20 mg showed a 50% and 44% reduction in nonvertebral fracture risk relative to placebo (p = 0.02) and raloxifene 60 mg (p = 0.05), respectively. Bazedoxifene significantly improved BMD and reduced bone marker levels (p < 0.001 versus placebo). The incidence of vasodilatation, leg cramps, and venous thromboembolic events was higher with bazedoxifene and raloxifene compared with placebo. In conclusion, bazedoxifene significantly reduced the risk of new vertebral fracture in postmenopausal women with osteoporosis and decreased the risk of nonvertebral fracture in subjects at higher fracture risk.