title: Assessment of Denosumab in Korean Postmenopausal Women with Osteoporosis: Randomized, Double-Blind, Placebo-Controlled Trial with Open-Label Extension.
abstract: OBJECTIVE
  The efficacy and safety of denosumab was compared with placebo in Korean postmenopausal women with osteoporosis in this phase III study.
  
  
  METHODS
  Women aged 60 to 90 years with a T-score of <-2.5 and ≥-4.0 at the lumbar spine or total hip were randomized to a single 60 mg subcutaneous dose of denosumab or placebo for the 6-month double-blind phase. Eligible subjects entered the 6-month open-label extension phase and received a single dose of denosumab 60 mg.
  
  
  RESULTS
  Baseline demographics were similar in the 62 denosumab- and 64 placebo-treated subjects who completed the double-blind phase. Treatment favored denosumab over placebo for the primary endpoint {mean percent change from baseline in lumbar spine bone mineral density (BMD) at Month 6 [3.2% (95% confidence interval 2.1%, 4.4%; p<0.0001)]}; and secondary endpoints (mean percent change from baseline in lumbar spine BMD at Month 1, total hip, femoral neck, and trochanter BMD at Months 1 and 6, and median percent change from baseline in bone turnover markers at Months 1, 3, and 6). Endpoint improvements were sustained over 12 months in the open-label extension (n=119). There were no new or unexpected safety signals.
  
  
  CONCLUSIONS
  Denosumab was well tolerated and effective in increasing BMD and decreasing bone turnover markers over a 12-month period in Korean postmenopausal women. The findings of this study demonstrate that denosumab has beneficial effects on the measures of osteoporosis in Korean postmenopausal women.
authors.affiliation: Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jung Min
authors.initials: JM
authors.lastname: Koh
authors.affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
authors.forename: Dong Jin
authors.initials: DJ
authors.lastname: Chung
authors.affiliation: Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Korea.
authors.forename: Yoon Sok
authors.initials: YS
authors.lastname: Chung
authors.affiliation: Department of Endocrinology and Metabolism, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
authors.forename: Moo Il
authors.initials: MI
authors.lastname: Kang
authors.affiliation: Department of Endocrinology and Metabolism, Pusan National University Hospital, Busan, Korea.
authors.forename: In Ju
authors.initials: IJ
authors.lastname: Kim
authors.affiliation: Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Yong Ki
authors.initials: YK
authors.lastname: Min
authors.affiliation: Department of Family Medicine, Cheil General Hospital, College of Medicine, Kwandong University, Seoul, Korea.
authors.forename: Han Jin
authors.initials: HJ
authors.lastname: Oh
authors.affiliation: Department of Orthopedic Surgery, Kyungpook National University Hospital, Daegu, Korea.
authors.forename: Il Hyung
authors.initials: IH
authors.lastname: Park
authors.affiliation: GlaxoSmithKline, Seoul, Korea.
authors.forename: Yil Seob
authors.initials: YS
authors.lastname: Lee
authors.affiliation: GlaxoSmithKline, Collegeville, PA, USA. barbara.g.kravitz@gsk.com.
authors.forename: Barbara
authors.initials: B
authors.lastname: Kravitz
authors.affiliation: GlaxoSmithKline, Collegeville, PA, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Waterhouse
authors.affiliation: GlaxoSmithKline, Collegeville, PA, USA.
authors.forename: Antonio
authors.initials: A
authors.lastname: Nino
authors.affiliation: GlaxoSmithKline, Collegeville, PA, USA.
authors.forename: Lorraine A
authors.initials: LA
authors.lastname: Fitzpatrick
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D044466:Asian People; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D000069448:Denosumab / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005269:Femur; D005272:Femur Neck; D006801:Humans; D008159:Lumbar Vertebrae; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000208:ethnology*; D017698:Postmenopause; D056910:Republic of Korea
chemical_list: D050071:Bone Density Conservation Agents; D000069448:Denosumab
keywords: Denosumab; Korea; biochemical markers of bone turnover; bone mineral density; postmenopausal osteoporosis