Safety of bazedoxifene in a randomized, double-blind, placebo- and active-controlled Phase 3 study of postmenopausal women with osteoporosis

• Published in: BMC musculoskeletal disorders Vol. 11; no. 1; p. 130
• Main Authors: Christiansen, Claus, Chesnut, 3rd, Charles H, Adachi, Jonathan D, Brown, Jacques P, Fernandes, César E, Kung, Annie Wc, Palacios, Santiago, Levine, Amy B, Chines, Arkadi A, Constantine, Ginger D
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 22.06.2010; BioMed Central; BMC
• Subjects: Aged; Aged, 80 and over; Antagonists; Bone density; Bone Density Conservation Agents - administration & dosage; Bone Density Conservation Agents - adverse effects; Care and treatment; Double-Blind Method; Estrogen; Estrogens; Female; Health aspects; Humans; Indoles - administration & dosage; Indoles - adverse effects; Menopause; Middle Aged; Osteoporosis; Osteoporosis, Postmenopausal - drug therapy; Osteoporosis, Postmenopausal - physiopathology; Placebos; Postmenopausal women; Prevention; Raloxifene Hydrochloride - administration & dosage; Raloxifene Hydrochloride - adverse effects; Selective Estrogen Receptor Modulators - administration & dosage; Selective Estrogen Receptor Modulators - adverse effects; Treatment Outcome; Women

We report the safety findings from a 3-year phase 3 study (NCT00205777) of bazedoxifene, a novel selective estrogen receptor modulator under development for the prevention and treatment of postmenopausal osteoporosis. Healthy postmenopausal osteoporotic women (N = 7,492; mean age, 66.4 years) were r...