HONOLULU — Bazedoxifene is effective in preventing osteoporosis in postmenopausal women, according to the results of a 2-year, phase III, placebo-controlled trial presented at the annual meeting of the American Society for Bone and Mineral Research.
Participants were postmenopausal women aged 45 years, whose femoral neck bone or lumbar spine T scores were above −2.5. Women with vasomotor symptoms, bone diseases, prior vertebral fractures, or endometrial hyperplasia, were excluded.
A total of 1,583 postmenopausal women were randomized to daily bazedoxifene regimens of 10 mg, 20 mg, or 40 mg, or to raloxifene (60 mg), or to placebo. All received a daily 600-mg calcium supplement.
Of the total, 1,113 (70%) completed the study. More than 90% in each group were white. Mean range in body mass index (kg/m
By month 24, BMD loss was prevented in all groups except in women using placebo, who had a significant decline in BMD. The percent change in lumbar spine BMD from baseline (relative to placebo) was 1.1%, 1.4%, and 1.5%, for bazedoxifene 10 mg, 20 mg, and 40 mg, respectively; it was 1.5% for raloxifene 60 mg. Similar dose-response results were found at other skeletal sites for those on bazedoxifene. Adverse event rates were similar among the groups. The study was supported by Wyeth Research and Wyeth Pharmaceuticals.