title: Effects of bazedoxifene on bone mineral density, bone turnover, and safety in postmenopausal Japanese women with osteoporosis.
abstract: 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 < .001 for both). Both bazedoxifene doses significantly improved BMD at the total hip, femoral neck, and greater trochanter compared with placebo (p < .001 for all). Decreases in bone turnover markers were observed with bazedoxifene 20 and 40 mg as early as 12 weeks (p < .05 for all) and were sustained throughout the study. Total and low-density lipoprotein cholesterol levels were significantly decreased from baseline with both bazedoxifene doses compared with placebo (p < .05 for all). Incidences of new vertebral and nonvertebral fractures were similar among the bazedoxifene and placebo groups. Overall, the incidence of adverse events with bazedoxifene 20 and 40 mg was similar to that with placebo. Bazedoxifene significantly improved BMD, reduced bone turnover, and was well tolerated in postmenopausal Japanese women with osteoporosis.
authors.affiliation: Saitama Center for Bone Research, Saitama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Itabashi
authors.forename: Kousei
authors.initials: K
authors.lastname: Yoh
authors.forename: Arkadi A
authors.initials: AA
authors.lastname: Chines
authors.forename: Takami
authors.initials: T
authors.lastname: Miki
authors.forename: Masahiko
authors.initials: M
authors.lastname: Takada
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sato
authors.forename: Itsuo
authors.initials: I
authors.lastname: Gorai
authors.forename: Toshitsugu
authors.initials: T
authors.lastname: Sugimoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Mizunuma
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ochi
authors.forename: Ginger D
authors.initials: GD
authors.lastname: Constantine
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ohta
mesh_terms: D044466:Asian People; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D016723:Bone Remodeling / Q000187:drug effects*; D003710:Demography; D005260:Female; D006801:Humans; D015994:Incidence; D007211:Indoles / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D050356:Lipid Metabolism / Q000187:drug effects; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology*; D058866:Osteoporotic Fractures / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000503:physiopathology
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D007211:Indoles; C447119:bazedoxifene