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Osteoporosis International

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01-02-2011 | Original Article

Efficacy and safety of bazedoxifene in postmenopausal Asian women

Authors: L. Xu, K.-S. Tsai, G. S. Kim, Y. Wu, P. Vincendon, A. A. Chines, G. D. Constantine

Published in: Osteoporosis International | Issue 2/2011

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.

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Title: Efficacy and safety of bazedoxifene in postmenopausal Asian women
Authors: L. Xu
K.-S. Tsai
G. S. Kim
Y. Wu
P. Vincendon
A. A. Chines
G. D. Constantine
Publication date: 01-02-2011
Publisher: Springer-Verlag
Published in: Osteoporosis International / Issue 2/2011
Print ISSN: 0937-941X
Electronic ISSN: 1433-2965
DOI: https://doi.org/10.1007/s00198-010-1259-5

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Efficacy and safety of bazedoxifene in postmenopausal Asian women

Abstract

Summary

Introduction

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Summary

Introduction

Methods

Results

Conclusion

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