Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea
Background The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world cli...
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| Format: | Article |
| Language: | English |
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Korean Endocrine Society
2022-06-01
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| Series: | Endocrinology and Metabolism |
| Subjects: | |
| Online Access: | http://www.e-enm.org/upload/pdf/enm-2022-1427.pdf |
| _version_ | 1818533351847362560 |
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| author | Yumie Rhee Dong-Gune Chang Jeonghoon Ha Sooa Kim Yusun Lee Euna Jo Jung-Min Koh |
| author_facet | Yumie Rhee Dong-Gune Chang Jeonghoon Ha Sooa Kim Yusun Lee Euna Jo Jung-Min Koh |
| author_sort | Yumie Rhee |
| collection | DOAJ |
| description | Background The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice. Methods Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck. Results Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean±standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively. Conclusion The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings. |
| first_indexed | 2024-12-11T17:57:32Z |
| format | Article |
| id | doaj.art-d5b8568c8cbf484d94719850ef9c7fd6 |
| institution | Directory Open Access Journal |
| issn | 2093-596X 2093-5978 |
| language | English |
| last_indexed | 2024-12-11T17:57:32Z |
| publishDate | 2022-06-01 |
| publisher | Korean Endocrine Society |
| record_format | Article |
| series | Endocrinology and Metabolism |
| spelling | doaj.art-d5b8568c8cbf484d94719850ef9c7fd62022-12-22T00:56:01ZengKorean Endocrine SocietyEndocrinology and Metabolism2093-596X2093-59782022-06-0137349750510.3803/EnM.2022.14272300Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South KoreaYumie Rhee0Dong-Gune Chang1Jeonghoon Ha2Sooa Kim3Yusun Lee4Euna Jo5Jung-Min Koh6 Department of Internal Medicine, Severance Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea Department of Orthopedic Surgery, Inje University Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Korea Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea Amgen Korea Ltd., Seoul, Korea Amgen Korea Ltd., Seoul, Korea Amgen Korea Ltd., Seoul, Korea Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, KoreaBackground The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice. Methods Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck. Results Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean±standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively. Conclusion The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.http://www.e-enm.org/upload/pdf/enm-2022-1427.pdfbone densitydenosumabosteoporosispostmarketing drug surveillancesafetykorea |
| spellingShingle | Yumie Rhee Dong-Gune Chang Jeonghoon Ha Sooa Kim Yusun Lee Euna Jo Jung-Min Koh Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea Endocrinology and Metabolism bone density denosumab osteoporosis postmarketing drug surveillance safety korea |
| title | Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea |
| title_full | Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea |
| title_fullStr | Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea |
| title_full_unstemmed | Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea |
| title_short | Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea |
| title_sort | real world safety and effectiveness of denosumab in patients with osteoporosis a prospective observational study in south korea |
| topic | bone density denosumab osteoporosis postmarketing drug surveillance safety korea |
| url | http://www.e-enm.org/upload/pdf/enm-2022-1427.pdf |
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