Abstract | UNLABELLED: 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. INTRODUCTION: METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
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Authors | S L Silverman, A A Chines, D L Kendler, A W C Kung, C S Teglbjærg, D Felsenberg, N Mairon, G D Constantine, J D Adachi, Bazedoxifene Study Group |
Journal | Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
(Osteoporos Int)
Vol. 23
Issue 1
Pg. 351-63
(Jan 2012)
ISSN: 1433-2965 [Electronic] England |
PMID | 21779819
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bone Density Conservation Agents
- Indoles
- Placebos
- Selective Estrogen Receptor Modulators
- bazedoxifene
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Topics |
- Aged
- Bone Density
(drug effects)
- Bone Density Conservation Agents
(administration & dosage, adverse effects, therapeutic use)
- Bone Remodeling
(drug effects)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Follow-Up Studies
- Humans
- Indoles
(administration & dosage, adverse effects, therapeutic use)
- Middle Aged
- Osteoporosis, Postmenopausal
(complications, drug therapy)
- Osteoporotic Fractures
(etiology, prevention & control)
- Placebos
- Selective Estrogen Receptor Modulators
(administration & dosage, adverse effects, therapeutic use)
- Spinal Fractures
(etiology, prevention & control)
- Treatment Outcome
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