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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.
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.
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.