Miller PD et al. (2008) Effects of bazedoxifene on BMD and bone turnover in postmenopausal women: 2-yr results of a randomized, double-blind, placebo-, and active-controlled study. J Bone Miner Res 23: 525–535

A phase III trial that compared bazedoxifene, a novel selective estrogen receptor modulator, with raloxifene and placebo has shown that bazedoxifene prevents bone loss and increases BMD in postmenopausal women. Whereas placebo-treated participants' BMD declined throughout the study, bazedoxifene was as effective as raloxifene in preventing bone loss.

Miller et al. enrolled 1,583 postmenopausal women with low BMD and/or risk factors for osteoporosis in their 2-year, multicenter trial. Participants were randomly allocated to bazedoxifene 10 mg, 20 mg or 40 mg, raloxifene 60 mg, or placebo. At 6 months, lumbar spine and total hip BMD were significantly higher in all intervention groups than in the placebo group (P <0.001); this effect was maintained until the final BMD measurement at 24 months. The 20 mg and 40 mg doses of bazedoxifene were significantly (P <0.05) better than the 10 mg dose at protecting femoral-neck BMD. Women in all intervention groups experienced significant (P <0.001) reductions in serum osteocalcin and C-telopeptide levels compared with placebo-treated women. The study was completed by 911 women; withdrawals and adverse events were similar between groups. The most common treatment-related adverse events were headache, infection, arthralgia, pain and hot flashes; the incidence of hot flashes was higher in the intervention groups than the placebo group. Of six deaths, one (due to pulmonary embolism) was considered to be possibly treatment-related.