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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/19854

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
Authors: Hadji, P.
Papaioannou, N.
Gielen, Ellen
Tepie, M. Feudjo
Zhang, E.
Frieling, I.
Geusens, Piet
Makras, P.
Resch, H.
Moeller, G.
Kalouche-Khalil, L.
Fahrleitner-Pammer, A.
Issue Date: 2015
Citation: OSTEOPOROSIS INTERNATIONAL, 26 (10), p. 2479-2489
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. Introduction 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.
Notes: [Hadji, P.] Krankenhaus NW Frankfurt, Dept Obstet & Gynecol, D-60488 Frankfurt, Germany. [Papaioannou, N.] Univ Athens, Sch Med, Lab Res Myoskeletal Dis, KAT Hosp, GR-11527 Athens, Greece. [Gielen, E.] UZ Leuven, Dept Geriatr, Leuven, Belgium. [Gielen, E.] UZ Leuven, Ctr Metab Bone Dis, Leuven, Belgium. [Tepie, M. Feudjo; Zhang, E.] Amgen Ltd, Uxbridge, Middx, England. [Frieling, I.] Osteoporosis Ctr, Hamburg, Germany. [Geusens, P.] Maastricht Univ, Med Ctr, Dept Internal Med, Maastricht, Netherlands. [Geusens, P.] Univ Hasselt, Diepenbeek, Belgium. [Makras, P.] 251 Hellenic Airforce, Dept Endocrinol & Diabet, Athens, Greece. [Makras, P.] VA Gen Hosp, Athens, Greece. [Resch, H.] Med Univ Vienna, Acad Teaching Hosp, St Vincent Hosp, Dept Med 2, Vienna, Austria. [Moeller, G.] Practice Prevent & Regenerat Med, Staufen Im Breisgau, Germany. [Kalouche-Khalil, L.] Amgen Europe GmbH, Zug, Switzerland. [Fahrleitner-Pammer, A.] Med Univ Graz, Dept Endocrinol & Metab, Graz, Austria.
URI: http://hdl.handle.net/1942/19854
DOI: 10.1007/s00198-015-3164-4
ISI #: 000361639700010
ISSN: 0937-941X
Category: A1
Type: Journal Contribution
Validation: ecoom, 2016
Appears in Collections: Research publications

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