title: Persistence, adherence, and medication-taking behavior in women with postmenopausal osteoporosis receiving denosumab in routine practice in Germany, Austria, Greece, and Belgium: 12-month results from a European non-interventional study.
abstract: Persistence with and adherence to osteoporosis therapy are critical for fracture reduction. This non-interventional study is evaluating medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in Germany, Austria, Greece, and Belgium. Patients were representative of the PMO population and highly persistent with and adherent to denosumab at 12 months.
  
  
  BACKGROUND
  Persistence with and adherence to osteoporosis therapy are important for optimal treatment efficacy, namely fracture reduction. This ongoing, non-interventional study will evaluate medication-taking behavior of women with postmenopausal osteoporosis (PMO) receiving denosumab in routine practice in four European countries.
  
  
  METHODS
  The study enrolled women who had been prescribed subcutaneous denosumab (60 mg every 6 months) in accordance with prescribing information and local guidelines. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection. Adherence was defined as receiving two consecutive injections within 6 months ± 4 weeks of each other. Medication coverage ratio (MCR) was calculated using the time a patient was covered with denosumab, as assessed from prescription records. Treatment was assigned prior to and independently of enrollment; outcomes are recorded during routine practice.
  
  
  RESULTS
  These planned 12-month interim analyses included data from 1500 patients from 141 sites. Mean age was 66.4-72.4 years, mean baseline total hip T-scores ranged from -2.0 to -2.1 and femoral neck T-scores from -2.2 to -2.6, and 30.7-62.1% of patients had prior osteoporotic fracture. Persistence was 87.0-95.3%, adherence 82.7-89.3%, and MCR 91.3-95.4%. In a univariate analysis, increased age, decreased mobility, and increased distance to the clinic were associated with significantly decreased persistence; parental history of hip fracture was associated with significantly increased persistence.
  
  
  CONCLUSIONS
  These data extend the real-world evidence regarding persistence with and adherence to denosumab, both of which are critical for favorable clinical outcomes, including fracture risk reduction.
authors.affiliation: Department of Obstetrics and Gynecology, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488, Frankfurt, Germany. hadji.peyman@khnw.de.
authors.forename: P
authors.initials: P
authors.lastname: Hadji
authors.affiliation: Medical School, Laboratory of Research of Myoskeletal Diseases, KAT Hospital, University of Athens, Athens, Greece.
authors.forename: N
authors.initials: N
authors.lastname: Papaioannou
authors.affiliation: Department of Geriatrics and the Centre for Metabolic Bone Diseases, UZ Leuven, Leuven, Belgium.
authors.forename: E
authors.initials: E
authors.lastname: Gielen
authors.affiliation: Amgen Ltd, Uxbridge, UK.
authors.forename: M
authors.initials: M
authors.lastname: Feudjo Tepie
authors.affiliation: Amgen Ltd, Uxbridge, UK.
authors.forename: E
authors.initials: E
authors.lastname: Zhang
authors.affiliation: Osteoporosis Center, Hamburg, Germany.
authors.forename: I
authors.initials: I
authors.lastname: Frieling
authors.affiliation: Department of Internal Medicine, Maastricht University Medical Centre, Maastricht, Netherlands.|University Hasselt, Diepenbeek, Belgium.
authors.forename: P
authors.initials: P
authors.lastname: Geusens
authors.affiliation: Department of Endocrinology and Diabetes, 251 Hellenic Airforce and VA General Hospital, Athens, Greece.
authors.forename: P
authors.initials: P
authors.lastname: Makras
authors.affiliation: St Vincent Hospital, Medical Department II, Academic Teaching Hospital of the Medical University of Vienna, Vienna, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Resch
authors.affiliation: Practice for Preventive and Regenerative Medicine, Staufen im Breisgau, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Möller
authors.affiliation: Amgen (Europe) GmbH, Zug, Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Kalouche-Khalil
authors.affiliation: Department of Endocrinology and Metabolism, Medical University Graz, Graz, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Fahrleitner-Pammer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D015897:Comorbidity; D000069448:Denosumab / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008511:Medicine / Q000706:statistics & numerical data; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D058866:Osteoporotic Fractures / Q000453:epidemiology / Q000517:prevention & control; D011446:Prospective Studies; D016903:Drug Monitoring
chemical_list: D050071:Bone Density Conservation Agents; D000069448:Denosumab
keywords: Adherence; Compliance; Denosumab; Non-interventional study; Osteoporosis; Persistence