This randomized, double-blind, placebo-controlled, dose-response late phase 2 study evaluated the efficacy and safety of
bazedoxifene in postmenopausal Japanese women 85 years of age or younger with
osteoporosis. Eligible subjects received daily treatment with oral doses of
bazedoxifene 20 or 40 mg or placebo for 2 years. Efficacy assessments included bone mineral density (BMD) at the lumbar spine and other skeletal sites, bone turnover marker levels,
lipid parameters, and incidence of new fractures. Of 429 randomized subjects, 387 were evaluable for efficacy, and 423 were included in the safety analyses (mean age, 64 years). At 2 years, the mean percent changes from baseline in lumbar spine BMD were significantly greater with
bazedoxifene 20 and 40 mg (2.43% and 2.74%, respectively) than with placebo (-0.65%, p < .001 for both). Both
bazedoxifene doses significantly improved BMD at the total hip, femoral neck, and greater trochanter compared with placebo (p < .001 for all). Decreases in bone turnover markers were observed with
bazedoxifene 20 and 40 mg as early as 12 weeks (p < .05 for all) and were sustained throughout the study. Total and
low-density lipoprotein cholesterol levels were significantly decreased from baseline with both
bazedoxifene doses compared with placebo (p < .05 for all). Incidences of new vertebral and nonvertebral fractures were similar among the
bazedoxifene and placebo groups. Overall, the incidence of adverse events with
bazedoxifene 20 and 40 mg was similar to that with placebo.
Bazedoxifene significantly improved BMD, reduced bone turnover, and was well tolerated in postmenopausal Japanese women with
osteoporosis.