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Title: Factors associated with high 24-month persistence with denosumab: results of a real-world, non-interventional study of women with postmenopausal osteoporosis inGermany, Austria, Greece, and Belgium
Authors: Fahrleitner-Pammer, A.
Papaioannou, N.
GIELEN, Ellen 
Tepie, M. Feudjo
Toffis, C.
Frieling, I.
Makras, P.
Boschitsch, E.
Callens, J.
Anastasilakis, A. D.
Niedhart, C.
Resch, H.
Kalouche-Khalil, L.
Hadji, P.
Issue Date: 2017
Source: ARCHIVES OF OSTEOPOROSIS, 12(1), p. 1-13 (Art N° 58)
Abstract: Persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium found that persistence with denosumab remains consistently high after 24 months in patients at high risk of fracture. Purpose Continued persistence with osteoporosis therapy is vital for fracture prevention. This non-interventional study of clinical practice evaluated medication-taking behavior of postmenopausal women receiving denosumab in Germany, Austria, Greece, and Belgium and factors influencing persistence. Methods Subcutaneous denosumab (60 mg every 6 months) was assigned according to prescribing information and local guidelines before and independently of enrollment; outcomes were recorded during routine practice for up to 24 months. Persistence was defined as receiving the subsequent injection within 6 months + 8 weeks of the previous injection and adherence as administration of subsequent injections within 6 months +/- 4 weeks of the previous injection. Medication coverage ratio (MCR) was calculated as the proportion of time a patient was covered by denosumab. Associations between pre-specified baseline covariates and 24-month persistence were assessed using multivariable logistic regression. Results The 24-month analyses included 1479 women (mean age 66.3-72.5 years) from 140 sites; persistence with denosumab was 75.1-86.0%, adherence 62.9-70.1%, and mean MCR 87.4-92.4%. No covariate had a significant effect on persistence across all four countries. For three countries, a recent fall decreased persistence; patients were generally older with chronic medical conditions. In some countries, other covariates (e.g., older age, comorbidity, immobility, and prescribing reasons) decreased persistence. Adverse drug reactions were reported in 2.3-6.9% patients. Conclusions Twenty-four-month persistence with denosumab is consistently high among postmenopausal women in Europe and may be influenced by patient characteristics. Further studies are needed to identify determinants of low persistence.
Notes: [Fahrleitner-Pammer, A.] Med Univ Graz, Dept Endocrinol & Metab, Graz, Austria. [Papaioannou, N.] Univ Athens, Sch Med, Lab Res Musculoskeletal Syst, KAT Hosp, Athens, Greece. [Gielen, E.] UZ Leuven, Dept Geriatr, Leuven, Belgium. [Gielen, E.] UZ Leuven, Ctr Metab Bone Dis, Leuven, Belgium. [Tepie, M. Feudjo] Amgen Ltd, Uxbridge, Middx, England. [Toffis, C.] Amgen Ltd, Cambridge, 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 Hellen Airforce & VA Gen Hosp, Dept Endocrinol & Diabet, Athens, Greece. [Boschitsch, E.] Menopause & Osteoporosis Clin, Ambulatorium KLIMAX, Vienna, Austria. [Callens, J.] AZ Zeno, Dept Orthoped Rheumatol & Phys Med & Rehabil, Knokke, Belgium. [Anastasilakis, A. D.] 424 Gen Mil Hosp, Dept Endocrinol, Thessaloniki, Greece. [Niedhart, C.] Osteoporosis Ctr, Heinsberg, Germany. [Resch, H.] Med Univ Vienna, Dept Med 2, St Vincent Hosp, Acad Teaching Hosp, Vienna, Austria. [Resch, H.] Sigmund Freud Univ, Fac Med, Vienna, Austria. [Kalouche-Khalil, L.] Amgen Europe GmbH, Zug, Switzerland. [Hadji, P.] Krankenhaus NW Frankfurt, Dept Obstet & Gynecol, Frankfurt, Germany.
Keywords: adherence; compliance; denosumab; non-interventional study; osteoporosis; persistence;Adherence; Compliance; Denosumab; Non-interventional study; Osteoporosis; Persistence
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ISSN: 1862-3522
e-ISSN: 1862-3514
DOI: 10.1007/s11657-017-0351-2
ISI #: 000404328300001
Rights: Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Category: A1
Type: Journal Contribution
Appears in Collections:Research publications

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