Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal japanese women with osteoporosis

This randomized, double‐blind, placebo‐controlled, dose‐response late phase 2 study evaluated the efficacy and safety of bazedoxifene in postmenopausal Japanese women 85 years of age or younger with osteoporosis. Eligible subjects received daily treatment with oral doses of bazedoxifene 20 or 40 mg...

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Bibliographic Details
Published in:Journal of bone and mineral research 2011-03, Vol.26 (3), p.519-529
Main Authors: Itabashi, Akira, Yoh, Kousei, Chines, Arkadi A, Miki, Takami, Takada, Masahiko, Sato, Hiroshi, Gorai, Itsuo, Sugimoto, Toshitsugu, Mizunuma, Hideki, Ochi, Hiroshi, Constantine, Ginger D, Ohta, Hiroaki
Format: Article
Language:English
Subjects:
Asian Continental Ancestry Group
BAZEDOXIFENE
Biological and medical sciences
Biomarkers - blood
Bone Density - drug effects
Bone Density Conservation Agents - adverse effects
Bone Density Conservation Agents - pharmacology
Bone Density Conservation Agents - therapeutic use
BONE MINERAL DENSITY
Bone Remodeling - drug effects
Demography
Female
Fundamental and applied biological sciences. Psychology
Humans
Incidence
Indoles - adverse effects
Indoles - pharmacology
Indoles - therapeutic use
Japan - epidemiology
Lipid Metabolism - drug effects
Middle Aged
Osteoporosis, Postmenopausal - blood
Osteoporosis, Postmenopausal - complications
Osteoporosis, Postmenopausal - drug therapy
Osteoporosis, Postmenopausal - physiopathology
Osteoporotic Fractures - complications
Osteoporotic Fractures - drug therapy
Osteoporotic Fractures - epidemiology
Osteoporotic Fractures - physiopathology
POSTMENOPAUSAL OSTEOPOROSIS
SERMS
Skeleton and joints
TREATMENTS
Vertebrates: osteoarticular system, musculoskeletal system
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Summary:This randomized, double‐blind, placebo‐controlled, dose‐response late phase 2 study evaluated the efficacy and safety of bazedoxifene in postmenopausal Japanese women 85 years of age or younger with osteoporosis. Eligible subjects received daily treatment with oral doses of bazedoxifene 20 or 40 mg or placebo for 2 years. Efficacy assessments included bone mineral density (BMD) at the lumbar spine and other skeletal sites, bone turnover marker levels, lipid parameters, and incidence of new fractures. Of 429 randomized subjects, 387 were evaluable for efficacy, and 423 were included in the safety analyses (mean age, 64 years). At 2 years, the mean percent changes from baseline in lumbar spine BMD were significantly greater with bazedoxifene 20 and 40 mg (2.43% and 2.74%, respectively) than with placebo (−0.65%, p 
ISSN:0884-0431
1523-4681
DOI:10.1002/jbmr.252