Long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis: 3-year post-marketing surveillance study
| Autor: | Naoki Okubo, Hideki Mizutani, Kiyoka Kuge, Ryoko Fukuda, Sakae Tanaka, Eri Tsuruya |
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| Rok vydání: | 2021 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Time Factors Endocrinology Diabetes and Metabolism Osteoporosis Postmarketing surveillance 030209 endocrinology & metabolism Bone remodeling 03 medical and health sciences 0302 clinical medicine Endocrinology Asian People Japan Bone Density Internal medicine Product Surveillance Postmarketing medicine Humans Orthopedics and Sports Medicine Hypocalcaemia Prospective Studies Adverse effect Aged Bone mineral Bone Density Conservation Agents Hypocalcemia business.industry Incidence General Medicine medicine.disease Treatment Outcome Denosumab Multivariate Analysis Female Bone Remodeling 030101 anatomy & morphology business Osteonecrosis of the jaw Biomarkers Osteoporotic Fractures medicine.drug |
| Zdroj: | Journal of Bone and Mineral Metabolism. 39:463-473 |
| ISSN: | 1435-5604 0914-8779 |
| DOI: | 10.1007/s00774-020-01180-4 |
| Popis: | Denosumab is a humanized IgG2 monoclonal antibody that was approved for the treatment of osteoporosis in Japan in 2013. This study aimed to investigate the long-term safety and effectiveness of denosumab in Japanese patients with osteoporosis in daily clinical practice. This 3-year, prospective, observational, post-marketing study included patients who initiated treatment with denosumab (60 mg/6 months) for osteoporosis. Data were assessed at baseline, 3, 6, 12, 24 and 36 months. Key endpoints were adverse events (AEs), adverse drug reactions (ADRs), occurrence of osteoporotic fractures, bone mineral density (BMD), and bone turnover markers. Multivariate analyses were conducted to identify predictors of hypocalcaemia and percent change in BMD. Overall, 3534 patients were assessed (mean 75.7 years; 89.8% women). In total, 298 patients (8.4%) developed ADRs; the most common was hypocalcaemia (3.9%). Hypocalcaemia risk was significantly increased in patients with creatinine clearance |
| Databáze: | OpenAIRE |
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