title: A 7-year randomized, placebo-controlled trial assessing the long-term efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis: effects on bone density and fracture.
abstract: OBJECTIVE
  In a 3-year randomized, double-blind, osteoporosis treatment study (N = 7,492), bazedoxifene 20 mg and bazedoxifene 40 mg significantly (P < 0.05) reduced the risk of new vertebral fractures by 42% and 37%, respectively, compared with placebo in postmenopausal women with osteoporosis. This study evaluated the long-term (7-y) efficacy and safety of bazedoxifene in generally healthy postmenopausal women with osteoporosis.
  
  
  METHODS
  This was a second 2-year extension of the 3-year multicenter outpatient core study. During extension I (years 4-5), women receiving bazedoxifene 40 mg transitioned to bazedoxifene 20 mg. In extension II (years 6-7; N = 1,530), all bazedoxifene-treated women continued bazedoxifene 20 mg. Main outcome measures included year 7 endpoints: incidences of new vertebral and nonvertebral fractures, bone mineral density changes, and safety assessments.
  
  
  RESULTS
  At 7 years, the cumulative incidences of new vertebral fractures were significantly lower in the bazedoxifene (6.4%) and bazedoxifene 20 mg (7.6%) groups than in the placebo group (9.9%); the relative risk reductions were 36.5% and 30.4%, respectively (both P < 0.001). Bazedoxifene had no effect on the overall incidence of nonvertebral fractures (bazedoxifene, 11.2%; bazedoxifene 20 mg, 12.0%; placebo, 10.8%). The mean changes from baseline in lumbar spine bone mineral density were 2.95%, 2.73%, and 2.19%, respectively. Seven-year decreases in total hip bone mineral density were significantly smaller in the bazedoxifene (-1.15%) and bazedoxifene 20 mg (-1.19%) groups than in the placebo group (-2.53%; P ≤ 0.002). Bazedoxifene showed a favorable safety/tolerability profile across 7 years, with similar adverse events, serious adverse events, and study discontinuations in all groups.
  
  
  CONCLUSIONS
  Efficacy and safety of bazedoxifene are sustained across 7 years in postmenopausal women with osteoporosis.
authors: From the 1Palacios Institute of Women's Health, Madrid, Spain; 2Cedars-Sinai Medical Center and University of California, Los Angeles, CA; 3MediClinic Panorama and Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa; 4Pfizer Inc, Collegeville, PA; 5University Hospital, Ghent, Belgium; 6CHU de Québec Research Center, Laval University, Quebec City, QC, Canada; and 7Università Cattolica del Sacro Cuore, Rome, Italy.
authors: Santiago
authors: S
authors: Palacios
authors: Stuart L
authors: SL
authors: Silverman
authors: Tobie J
authors: TJ
authors: de Villiers
authors: Amy B
authors: AB
authors: Levine
authors: Stefan
authors: S
authors: Goemaere
authors: Jacques P
authors: JP
authors: Brown
authors: Fiorenzo
authors: F
authors: De Cicco Nardone
authors: Robert
authors: R
authors: Williams
authors: Teresa L
authors: TL
authors: Hines
authors: Sebastian
authors: S
authors: Mirkin
authors: Arkadi A
authors: AA
authors: Chines
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology* / Q000209:etiology; D006801:Humans; D015994:Incidence; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008159:Lumbar Vertebrae / Q000187:drug effects; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D010384:Pelvic Bones / Q000187:drug effects; D017698:Postmenopause; D013995:Time; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D007211:Indoles; C447119:bazedoxifene