Persistence at 12 months with denosumab in postmenopausal women with osteoporosis: interim results from a prospective observational study
| Autor: | Bradley S. Stolshek, S. Siddhanti, Irene Ferreira, David L. Kendler, P.R. Ho, Stuart L. Silverman, Deborah T. Gold, Christine Simonelli, Alexandra Papaioannou, A. Balasubramanian, C. Recknor, D. Belazi, E. M. Lewiecki, Jacques P. Brown, Ethel S. Siris, P. Dakin |
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| Jazyk: | angličtina |
| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Canada Bone density Endocrinology Diabetes and Metabolism Injections Subcutaneous Osteoporosis Antibodies Monoclonal Humanized Drug Administration Schedule Medication Adherence Persistence Bone Density Internal medicine Observational study medicine Humans Prospective Studies Adverse effect Prospective cohort study Osteoporosis Postmenopausal Femoral neck Aged Aged 80 and over Hip fracture Lumbar Vertebrae Bone Density Conservation Agents business.industry Femur Neck Middle Aged medicine.disease Interim analysis United States Surgery medicine.anatomical_structure Denosumab Adherence Original Article Female business Osteoporotic Fractures medicine.drug Compliance |
| Zdroj: | Osteoporosis International |
| ISSN: | 1433-2965 0937-941X |
| Popis: | Summary 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. Introduction 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 5 years previously, lumbar spine T-score > −2.5, and treatment by female physicians (US). Lower persistence was associated (p |
| Databáze: | OpenAIRE |
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