Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study
- S. L. SilvermanAffiliated withCedars-Sinai Medical Center and University of CaliforniaOMC Clinical Research Center Email author
- , A. A. ChinesAffiliated withPfizer Inc
- , D. L. KendlerAffiliated withProhealth Research, University of British Columbia
- , A. W. C. KungAffiliated withDepartment of Medicine, The University of Hong Kong
- , C. S. TeglbjærgAffiliated withCenter for Clinical and Basic Research
- , D. FelsenbergAffiliated withCenter of Muscle and Bone Research, Charité University Medicine Berlin, Free University and Humboldt University
- , N. MaironAffiliated withWyeth Pharmaceuticals
- , G. D. ConstantineAffiliated withPfizer Inc
- , J. D. AdachiAffiliated withSt. Joseph’s Healthcare, McMaster University
- and 1 more
- , for the Bazedoxifene Study Group
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In this 2-year extension of a 3-year study, bazedoxifene showed sustained efficacy in preventing new vertebral fractures in postmenopausal women with osteoporosis and in preventing non-vertebral fractures in higher-risk women. Bazedoxifene significantly increased bone mineral density and reduced bone turnover versus placebo and was generally safe and well tolerated.
This study evaluated the efficacy and safety of bazedoxifene for the treatment of postmenopausal osteoporosis over 5 years.
A total of 4,216 postmenopausal women with osteoporosis were enrolled in this 2-year extension of a 3-year, randomized, double-blind, placebo-controlled, phase 3 trial. In the core study (N = 7,492), subjects received bazedoxifene 20 or 40 mg/day, raloxifene 60 mg/day, or placebo. The raloxifene arm was discontinued after 3 years; subjects receiving bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg after 4 years. Five-year findings are reported for bazedoxifene 20 and 40/20 mg and placebo. Endpoints included incidence of new vertebral fractures (primary) and non-vertebral fractures, and changes in bone mineral density (BMD) and bone turnover markers.
At 5 years, the incidence of new vertebral fractures in the intent-to-treat population was significantly lower with bazedoxifene 20 mg (4.5%) and 40/20 mg (3.9%) versus placebo (6.8%; P < 0.05), with relative risk reductions of 35% and 40%, respectively. Non-vertebral fracture incidence was similar among groups. In a subgroup of higher-risk women (n = 1,324; femoral neck T-score ≤−3.0 and/or ≥1 moderate or severe or ≥2 mild vertebral fracture[s]), bazedoxifene 20 mg reduced non-vertebral fracture risk versus placebo (37%; P = 0.06); combined data for bazedoxifene 20 and 40/20 mg reached statistical significance (34% reduction; P < 0.05). Bazedoxifene significantly increased BMD and reduced bone turnover versus placebo (P < 0.05) and was generally safe and well tolerated.
The findings support a sustained anti-fracture effect of bazedoxifene on new vertebral fractures in postmenopausal osteoporotic women and on non-vertebral fractures in the higher-risk subgroup of women.
KeywordsBazedoxifene Fracture Osteoporosis Postmenopausal SERMs
- Sustained efficacy and safety of bazedoxifene in preventing fractures in postmenopausal women with osteoporosis: results of a 5-year, randomized, placebo-controlled study
Volume 23, Issue 1 , pp 351-363
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- 1. Cedars-Sinai Medical Center and University of California, Los Angeles, CA, USA
- 9. OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Beverly Hills, CA, 90211, USA
- 2. Pfizer Inc, Collegeville, PA, USA
- 3. Prohealth Research, University of British Columbia, Vancouver, British Columbia, Canada
- 4. Department of Medicine, The University of Hong Kong, Hong Kong, China
- 5. Center for Clinical and Basic Research, Ballerup, Denmark
- 6. Center of Muscle and Bone Research, Charité University Medicine Berlin, Free University and Humboldt University, Berlin, Germany
- 7. Wyeth Pharmaceuticals, Paris, France
- 8. St. Joseph’s Healthcare, McMaster University, Hamilton, Ontario, Canada