title: Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study.
abstract: To determine persistence with subcutaneous denosumab every 6 months in women being treated for osteoporosis, we conducted a single-arm prospective, observational study in the United States and Canada. Among 935 patients enrolled, 12-month persistence was 82%, with 66 patients (7%) reporting serious adverse events and 19 patients (2%) reporting fractures.
  
  
  BACKGROUND
  Increased persistence with osteoporosis therapy is associated with reduced fracture risk. Denosumab reduced fracture risk in clinical trials; persistence in community settings is undetermined. This study evaluates persistence with denosumab in community practice in the United States (US) and Canada.
  
  
  METHODS
  In a 24-month multicenter, prospective, single-arm, observational study, women being treated for osteoporosis were enrolled ≤4 weeks after the first subcutaneous injection of denosumab. For this 12-month prespecified interim analysis, endpoints include persistence (one injection at study entry and another within 6 months + 8 weeks), attributes associated with persistence (univariate analysis), and serious adverse events (SAEs).
  
  
  RESULTS
  Among 935 patients (mean age 71 years), mean baseline T-scores were -2.18 (femoral neck) and -2.00 (lumbar spine); 50% of patients had experienced osteoporotic fracture(s). At 12 months, 82 % of patients were persistent with denosumab. Baseline factors significantly (p < 0.05) associated with higher persistence included use of osteoporosis medications >5 years previously, lumbar spine T-score > -2.5, and treatment by female physicians (US). Lower persistence was associated (p < 0.05) with psychiatric diagnoses including depression, southern US residence, being divorced, separated, or widowed (US), and prior hip fracture (Canada). SAEs were reported in 66 patients (7%); no SAEs of osteonecrosis of the jaw, atypical femoral fracture, fracture healing complications, hypocalcemia, eczema, or hypersensitivity were reported. Nineteen patients (2%) reported osteoporotic fractures.
  
  
  CONCLUSIONS
  The 12-month persistence observed in this single-arm open-label study of US and Canadian community practice extends the evidence regarding denosumab's potential role in reducing fracture risk in postmenopausal women with osteoporosis.
authors.affiliation: Cedars-Sinai Medical Center and OMC Clinical Research Center, 8641 Wilshire Blvd, Suite 301, Los Angeles, CA, 90211, USA, stuarts@omcresearch.org.
authors.forename: S L
authors.initials: SL
authors.lastname: Silverman
authors.forename: E
authors.initials: E
authors.lastname: Siris
authors.forename: D L
authors.initials: DL
authors.lastname: Kendler
authors.forename: D
authors.initials: D
authors.lastname: Belazi
authors.forename: J P
authors.initials: JP
authors.lastname: Brown
authors.forename: D T
authors.initials: DT
authors.lastname: Gold
authors.forename: E M
authors.initials: EM
authors.lastname: Lewiecki
authors.forename: A
authors.initials: A
authors.lastname: Papaioannou
authors.forename: C
authors.initials: C
authors.lastname: Simonelli
authors.forename: I
authors.initials: I
authors.lastname: Ferreira
authors.forename: A
authors.initials: A
authors.lastname: Balasubramanian
authors.forename: P
authors.initials: P
authors.lastname: Dakin
authors.forename: P
authors.initials: P
authors.lastname: Ho
authors.forename: S
authors.initials: S
authors.lastname: Siddhanti
authors.forename: B
authors.initials: B
authors.lastname: Stolshek
authors.forename: C
authors.initials: C
authors.lastname: Recknor
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000627:therapeutic use; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D002170:Canada / Q000453:epidemiology; D000069448:Denosumab; D004334:Drug Administration Schedule; D005260:Female; D005272:Femur Neck / Q000503:physiopathology; D006801:Humans; D007279:Injections, Subcutaneous; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D058866:Osteoporotic Fractures / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D014481:United States / Q000453:epidemiology; D016903:Drug Monitoring
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D050071:Bone Density Conservation Agents; D000069448:Denosumab