Efficacy and safety of bazedoxifene in postmenopausal Asian women
Journal
Osteoporosis International
Journal Volume
22
Journal Issue
2
Pages
559-565
Date Issued
2011
Author(s)
Abstract
Summary: This 6-month study examined the efficacy and safety of bazedoxifene 20 mg in postmenopausal Asian women. Bazedoxifene showed statistically significant improvements over placebo in bone mineral density at all skeletal sites evaluated. Bazedoxifene significantly reduced bone turnover and had favorable effects on lipid parameters. Bazedoxifene was safe and well tolerated. Introduction: This 6-month, randomized, double-blind, placebo-controlled phase 3 study conducted in China, Korea, and Taiwan evaluated the efficacy and safety of bazedoxifene in postmenopausal Asian women. Methods: Generally, healthy postmenopausal Asian women (N=487; mean age, 57.2 years; mean lumbar spine bone mineral density [BMD], -1.1) were randomized to daily therapy with bazedoxifene 20 mg or placebo; all subjects received daily supplemental calcium carbonate 600 mg. The changes from baseline in BMD at the lumbar spine (primary end point) and at other skeletal sites, bone turnover markers, and lipid parameters were evaluated at 6 months. Safety assessments included adverse event (AE) reporting and physical/gynecologic examination. Results: At 6 months, women who received bazedoxifene 20 mg had significantly greater BMD compared with those receiving placebo at the lumbar spine (0.41% vs -0.32%, P<0.01), femoral neck (-0.08% vs -0.69%, P=0.014), trochanter (0.50% vs -0.23%, P=0.010), and total hip (-0.03% vs -0.77%, P<0.001), respectively. Bazedoxifene 20 mg was also associated with significant differences from placebo in median percent reductions from baseline in serum C-telopeptide (-21.8%, P<0.001) and osteocalcin (-12.9%, P<0.001) levels and total (-5.0%, P<0.001) and low-density lipoprotein cholesterol (-9.5%, P<0.001) levels. The incidence of AEs was not different between subjects treated with bazedoxifene and those who received placebo. Conclusion: Bazedoxifene was generally safe and effective in preventing bone loss in this short-term study of postmenopausal Asian women. ? 2010 International Osteoporosis Foundation and National Osteoporosis Foundation.
Subjects
Bazedoxifene; Bone mineral density; Osteoporosis; Postmenopausal; Prevention; SERMs
SDGs
Other Subjects
bazedoxifene; biological marker; calcium; calcium carbonate; carboxy terminal telopeptide; high density lipoprotein cholesterol; low density lipoprotein cholesterol; osteocalcin; placebo; triacylglycerol; adult; angina pectoris; arthralgia; article; Asian; body mass; bone density; bone turnover; brain infarction; calcium intake; China; clinical evaluation; double blind procedure; drug efficacy; drug induced headache; drug safety; drug tolerability; dyspepsia; endometrial disease; endometrium biopsy; female; femur neck; heart infarction; heart muscle ischemia; hot flush; human; hypertension; infection; Korea; leg cramp; leukorrhea; lipid analysis; lumbar spine; major clinical study; mastalgia; medical history; multicenter study; osteolysis; ovary cyst; pain; physical examination; postmenopause; postmenopause osteoporosis; priority journal; protein blood level; randomized controlled trial; risk factor; scoring system; side effect; smoking; systolic blood pressure; Taiwan; treatment duration; triacylglycerol blood level; upper respiratory tract infection; uterus disease; vagina bleeding; venous thromboembolism; vitamin supplementation; Asian Continental Ancestry Group; Bone Density; Bone Remodeling; China; Cholesterol, LDL; Collagen Type I; Double-Blind Method; Female; Humans; Indoles; Middle Aged; Osteocalcin; Peptides; Postmenopause; Republic of Korea; Selective Estrogen Receptor Modulators; Taiwan; Treatment Outcome
Type
journal article