Silverman SL et al. (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 [doi:10.1359/jbmr.080710]

A number of therapies are approved for the treatment and prevention of postmenopausal osteoporosis, but they might not be suitable for all women. Continued development of new therapeutic agents is, therefore, essential.

In an international, multicenter, double-blind, phase III study, Silverman et al. evaluated the safety and efficacy of bazedoxifene, a novel selective estrogen-receptor modulator, in treating postmenopausal women with osteoporosis. A total of 6,847 women (mean age 66.4 years) were randomly allocated to receive 20 mg bazedoxifene, 40 mg bazedoxifene, 60 mg raloxifene or placebo daily, together with calcium and vitamin D supplementation. Patients were monitored for changes in BMD, bone turnover markers, and incidence of vertebral and/or nonvertebral fractures over a 36 month period. Bazedoxifene reduced the risk of new vertebral fracture by 42% (20 mg dose) and 37% (40 mg dose) relative to placebo, and was comparable to raloxifene. A subgroup analysis of 1,782 women at high fracture risk revealed that bazedoxifene significantly reduced the incidence of nonvertebral fracture. In particular, the 20 mg dose of bazedoxifene reduced the nonvertebral fracture risk compared with placebo (50%) and raloxifene (44%). Both bazedoxifene groups showed greater increases in BMD and improvements in bone marker levels compared with the placebo group. Furthermore, both doses of bazedoxifene were generally well tolerated.

Silverman and colleagues conclude that bazedoxifene is a promising new therapy for the treatment of postmenopausal osteoporosis.