Endocrinol Metab.
2025 Feb;40(1):47-56. 10.3803/EnM.2024.2125.
Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use
- Ha J
1 - Lee YJ2,3
- Kim J4
- Jeong C5
- Lim Y6
- Lee J7
- Baek KH4
- on Behalf of the Catholic Medical Center Bone Research Group1
- Affiliations
-
- 1Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 2Department of Biostatistics, Korea University College of Medicine, Seoul, Korea
- 3Medical Excellence Inc., Seoul, Korea
- 4Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- 5Division of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Uijeongbu, Korea
- 6Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
- 7Division of Endocrinology and Metabolism, Department of Internal Medicine, Eunpyeong St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
- KMID: 2565250
- DOI: http://doi.org/10.3803/EnM.2024.2125
Abstract
- Osteoporosis management in post-menopausal women focuses on fracture prevention, with denosumab as a key therapeutic option. Despite its proven efficacy in reducing fracture risk and increasing bone mineral density (BMD) over 10 years, its long-term impact remains uncertain. We evaluated the literature on its efficacy and safety beyond the initial decade. Clinical trials and real-world studies confirm denosumab’s sustained efficacy, especially in lumbar spine BMD, with hip BMD stabilizing. Concerns about adverse events (AEs) like hypocalcemia and osteonecrosis of the jaw necessitate vigilant monitoring. Risks of atypical femoral fractures and malignancies also require attention, despite unclear links to treatment duration. Clinical guidelines for denosumab beyond 10 years are limited, emphasizing the need for careful monitoring. In certain scenarios, such as advanced chronic kidney disease, prolonged denosumab may be required to balance AE risks with fracture prevention benefits. Denosumab shows potential for long-term efficacy in augmenting BMD; however, monitoring for AEs is crucial to guide clinical decision-making effectively.
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