title: Treatment with denosumab reduces secondary fracture risk in women with postmenopausal osteoporosis.
abstract: OBJECTIVE
  A history of prior fracture is one of the strongest predictors of a future fragility fracture. In FREEDOM, denosumab significantly reduced the risk of new vertebral, non-vertebral, and hip fractures. We carried out a post-hoc analysis of FREEDOM to characterize the efficacy of denosumab in preventing secondary fragility fractures in subjects with a prior fracture.
  
  
  METHODS
  A total of 7808 women aged 60-90 years with a bone mineral density T-score of less than - 2.5 but not less than - 4.0 at either the lumbar spine or total hip were randomized to subcutaneous denosumab 60 mg or placebo every 6 months for 36 months. The anti-fracture efficacy of denosumab was analyzed by prior fracture status, to assess secondary fragility fracture, and by subject age, prior fracture site and history of prior osteoporosis medication use.
  
  
  RESULTS
  A prior fragility fracture was reported for 45% of the overall study population. Compared with placebo, denosumab significantly reduced the risk of a secondary fragility fracture by 39% (incidence, 17.3% vs. 10.5%; p < 0.0001). Similar results were observed regardless of age or prior fracture site. In the overall population, denosumab significantly reduced the risk of a fragility fracture by 40% (13.3% vs. 8.0%; p < 0.0001), with similar results observed regardless of history of prior osteoporotic medication use.
  
  
  CONCLUSIONS
  Denosumab reduced the risk of fragility fractures to a similar degree in all risk subgroups examined, including those with prior fragility fractures. Identifying and treating high-risk individuals could help to close the current care gap in secondary fracture prevention.
authors.affiliation: a * Institute of Women's Health , Madrid , Spain.
authors.forename: S
authors.initials: S
authors.lastname: Palacios
authors.affiliation: b Amgen (Europe) GmbH , Zug , Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Kalouche-Khalil
authors.affiliation: c Geneva University Hospitals, Faculty of Medicine , Geneva , Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Rizzoli
authors.affiliation: d Amgen Inc. , Thousand Oaks , CA , USA.
authors.forename: C
authors.initials: C
authors.lastname: Zapalowski
authors.affiliation: e St Vincent Hospital , Vienna , Austria.
authors.forename: H
authors.initials: H
authors.lastname: Resch
authors.affiliation: f St Joseph's Healthcare, McMaster University , Hamilton , ON , Canada.
authors.forename: J D
authors.initials: JD
authors.lastname: Adachi
authors.affiliation: g Creighton University Medical School , Omaha , NE , USA.
authors.forename: J C
authors.initials: JC
authors.lastname: Gallagher
authors.affiliation: h Senior Clinical Trials Inc. , Laguna Hills , CA , USA.
authors.forename: R G
authors.initials: RG
authors.lastname: Feldman
authors.affiliation: i University of British Columbia , Vancouver , BC , Canada.
authors.forename: D L
authors.initials: DL
authors.lastname: Kendler
authors.affiliation: d Amgen Inc. , Thousand Oaks , CA , USA.
authors.forename: A
authors.initials: A
authors.lastname: Wang
authors.affiliation: d Amgen Inc. , Thousand Oaks , CA , USA.
authors.forename: R B
authors.initials: RB
authors.lastname: Wagman
authors.affiliation: j University of Verona , Verona , Italy.
authors.forename: S
authors.initials: S
authors.lastname: Adami
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D000069448:Denosumab / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006620:Hip Fractures / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008159:Lumbar Vertebrae; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications; D012008:Recurrence; D012307:Risk Factors; D016103:Spinal Fractures / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*
chemical_list: D050071:Bone Density Conservation Agents; D000069448:Denosumab
keywords: DENOSUMAB; FRAGILITY FRACTURE; FREEDOM STUDY; POSTMENOPAUSAL OSTEOPOROSIS; SECONDARY FRACTURE PREVENTION