title: CE/BZA effects on bone and quality of life in European postmenopausal women: a pooled analysis.
abstract: OBJECTIVE
  To evaluate the efficacy of conjugated estrogens/bazedoxifene (CE/BZA) on bone mineral density (BMD), bone turnover markers (BTM), and menopause-specific quality of life (MENQOL) in European women.
  
  
  METHODS
  Data through 12 months were pooled from two double-blind, randomized, controlled trials in non-hysterectomized postmenopausal women who received CE/BZA or placebo. Women from European study sites with evaluable BMD (n = 60), BTM (n = 56), and MENQOL questionnaire (n = 236) data were included and compared with 1523 women from US study sites (n = 730 with evaluable data for bone outcomes).
  
  
  RESULTS
  At month 12, CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg, respectively, significantly improved BMD (adjusted difference vs. placebo) in lumbar spine (2.5%, 2.9%; both p ≤ 0.011) and total hip (1.7%, 2.2%, both p ≤ 0.002), significantly improved serum BTMs (osteocalcin: -31.1%, -33.1%; C-telopeptide: -48.5%, -36.8%) vs. placebo (osteocalcin: 6.7%, C-telopeptide: 4.2%; all p < 0.001), and significantly improved MENQOL vasomotor function scores (-2.1, -2.2) vs. placebo (-0.7; both p < 0.001). No significant treatment × subpopulation interactions were observed for any of the outcomes.
  
  
  CONCLUSIONS
  Twelve-month CE/BZA treatment prevented bone loss and improved vasomotor function in European postmenopausal women. Findings were similar to those in the subpopulation of women enrolled at US study sites.
authors.affiliation: a Krankenhaus Nordwest , Frankfurt , Germany ;
authors.forename: P
authors.initials: P
authors.lastname: Hadji
authors.affiliation: b Pfizer Inc , Collegeville , PA , USA ;
authors.forename: K A
authors.initials: KA
authors.lastname: Ryan
authors.affiliation: c Pfizer Inc , New York , NY , USA.
authors.forename: C-R
authors.initials: CR
authors.lastname: Yu
authors.affiliation: b Pfizer Inc , Collegeville , PA , USA ;
authors.forename: S
authors.initials: S
authors.lastname: Mirkin
authors.affiliation: b Pfizer Inc , Collegeville , PA , USA ;
authors.forename: Barry S
authors.initials: BS
authors.lastname: Komm
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects; D016723:Bone Remodeling / Q000187:drug effects; D024042:Collagen Type I / Q000097:blood; D004311:Double-Blind Method; D004967:Estrogens / Q000008:administration & dosage*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005060:Europe; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D015675:Osteocalcin / Q000097:blood; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000517:prevention & control; D010455:Peptides / Q000097:blood; D011788:Quality of Life; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D016896:Treatment Outcome; D014481:United States; D014666:Vasomotor System / Q000187:drug effects
chemical_list: D024042:Collagen Type I; D004967:Estrogens; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D010455:Peptides; D020845:Selective Estrogen Receptor Modulators; C052929:collagen type I trimeric cross-linked peptide; D015675:Osteocalcin; C447119:bazedoxifene
keywords: Conjugated estrogens; bazedoxifene; bone mineral density; menopause; vasomotor