title: Effects of denosumab on bone mineral density and bone turnover in patients with rheumatoid arthritis receiving concurrent glucocorticoids or bisphosphonates.
abstract: OBJECTIVE
  To report results of subgroup analyses of bone mineral density (BMD) and bone turnover markers from a randomised, double-blind, placebo-controlled, phase II study of denosumab, an investigational RANKL inhibitor, in patients with rheumatoid arthritis (RA) concurrently receiving treatment with bisphosphonates or glucocorticoids.
  
  
  METHODS
  Patients received subcutaneous placebo (n=75), denosumab 60 mg (n=71) or denosumab 180 mg (n=72) at baseline and 6 months. Assessments included dual x-ray absorptiometry scans of the lumbar spine and hip, and determination of levels of serum type I C-telopeptide (sCTx-I) and serum procollagen 1N-terminal peptide (P1NP).
  
  
  RESULTS
  Denosumab treatment increased mean lumbar spine and hip BMD and reduced sCTx-I and P1NP compared with placebo through 12 months, regardless of baseline BMD or marker levels or concomitant bisphosphonate or glucocorticoid use.
  
  
  CONCLUSIONS
  This study extends evidence that denosumab increases BMD and reduces bone turnover in patients with RA and may provide a new therapeutic option for reducing systemic bone loss in patients with RA.
authors.affiliation: Robin K Dore Inc, Tustin, CA, USA. rkdmail@sbcglobal.net
authors.forename: Robin K
authors.initials: RK
authors.lastname: Dore
authors.forename: Stanley B
authors.initials: SB
authors.lastname: Cohen
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Lane
authors.forename: William
authors.initials: W
authors.lastname: Palmer
authors.forename: William
authors.initials: W
authors.lastname: Shergy
authors.forename: Lifen
authors.initials: L
authors.lastname: Zhou
authors.forename: Huei
authors.initials: H
authors.lastname: Wang
authors.forename: Wayne
authors.initials: W
authors.lastname: Tsuji
authors.forename: Richard
authors.initials: R
authors.lastname: Newmark
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000494:pharmacology*; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy / Q000503:physiopathology*; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000494:pharmacology*; D016723:Bone Remodeling / Q000187:drug effects*; D000069448:Denosumab; D004164:Diphosphonates / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006621:Hip Joint / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D053245:RANK Ligand / Q000037:antagonists & inhibitors / Q000494:pharmacology*
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D005938:Glucocorticoids; D053245:RANK Ligand; C505688:TNFSF11 protein, human; D000069448:Denosumab