ECTS2013 Poster Presentations Osteoporosis: treatment (64 abstracts)
Design of a prospective observational study to evaluate persistence and adherence during denosumab treatment, and patient characteristics in postmenopausal women with osteoporosis in routine clinical practice
Maurille Feudjo Tepie 1 , Gerd Möller 2 , Peyman Hadji 3 , Irene Ferreira 4 , Suresh Siddhanti 5 , Stephen Boonen 6 , Astrid Fahrleitner-Pammer 7 & Nikos Papaioannou 8
1Amgen Ltd., Uxbridge, UK; 2Amgen Europe GmbH, Zug, Switzerland; 3Philipps University, Marburg, Germany; 4Amgen Ltd., Cambridge, UK; 5Amgen Inc., Thousand Oaks, California, USA; 6Leuven University, Leuven, Belgium; 7Medical University of Graz, Graz, Austria; 8University of Athens, Athens, Greece.
Treatment of postmenopausal osteoporosis (PMO) has been traditionally hampered by poor persistence and adherence to short-term (≤1-monthly) medications. The efficacy of 6-monthly (Q6M) denosumab treatment has been proven in clinical trials, but effectiveness will be dependent on persistence and adherence in routine clinical practice. This study is designed to evaluate real-world persistence and adherence to denosumab, and to establish how this is best assessed in long-acting injectable medications (LAIs). This will be an international, non-interventional, observational study in women with PMO. Treatment will be assigned prior to, and independent of, study enrolment considerations, and all subsequent information recorded as in routine clinical practice. The only deviation from routine care will be the completion of 2 patient-reported outcome questionnaires at enrolment: the 8-item Morisky Medication Adherence Scale and the 12-item Short Form 12 Generic Health-related Quality of Life instrument. Persistence will be assessed by whether injections are separated by no more than 6 months +8 week ‘time window’, and adherence assessed by whether injections occur within 6 months ±4 week time window of the previous injection. Other time windows will be considered as part of sensitivity analyses. Medication coverage ratio will be defined by the percentage of days the patient was covered with denosumab treatment (according to prescription records). All outcomes will be evaluated at 12 and 24 months. The results of this study will provide clinicians with insight into risk factors for patient non-persistence with, and non-adherence to, denosumab therapy, and determine optimal methods of evaluating these factors with Q6M denosumab treatment. This appropriately designed study will give further insight on potential measures of persistence and adherence in LAIs, inform clinical practice by providing information on these measures with denosumab, and evaluate patient risk factors for non-persistence and non-adherence to LAIs.
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