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Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea.
Rhee, Yumie; Chang, Dong-Gune; Ha, Jeonghoon; Kim, Sooa; Lee, Yusun; Jo, Euna; Koh, Jung-Min.
Affiliation
  • Rhee Y; Department of Internal Medicine, Severance Hospital, Endocrine Research Institute, Yonsei University College of Medicine, Seoul, Korea.
  • Chang DG; Department of Orthopedic Surgery, Inje University Sanggye Paik Hospital, College of Medicine, Inje University, Seoul, Korea.
  • Ha J; Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • Kim S; Amgen Korea Ltd., Seoul, Korea.
  • Lee Y; Amgen Korea Ltd., Seoul, Korea.
  • Jo E; Amgen Korea Ltd., Seoul, Korea.
  • Koh JM; Division of Endocrinology and Metabolism, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Endocrinol Metab (Seoul) ; 37(3): 497-505, 2022 06.
Article in En | MEDLINE | ID: mdl-35654577
ABSTRACT
BACKGRUOUND 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.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Osteoporosis / Osteoporosis, Postmenopausal / Bone Density Conservation Agents Type of study: Clinical_trials / Observational_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: Endocrinol Metab (Seoul) Year: 2022 Document type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Osteoporosis / Osteoporosis, Postmenopausal / Bone Density Conservation Agents Type of study: Clinical_trials / Observational_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Language: En Journal: Endocrinol Metab (Seoul) Year: 2022 Document type: Article