Risk factors for denosumab-related osteonecrosis of the jaw: a pharmacovigilance study using the U.S. FDA adverse event reporting system database
This study demonstrates that the risk of denosumab-related ONJ is multifactorial, driven by high-dose regimens (120 mg Q4w), specific polypharmacy (particularly concomitant bisphosphonates and glucocorticoids) and male sex. These findings underscore the need for prospective validation and mechanistic investigation into the underlying drug interactions.
Authors
- Xiaonian Han (ORCID: https://orcid.org/0000-0002-3511-605X)
- Guan Wang (ORCID: https://orcid.org/0000-0003-2341-3054)
- Hehe Bai (ORCID: https://orcid.org/0000-0001-7934-5121)
- Huan Li (ORCID: https://orcid.org/0000-0003-1204-8370)
- Jinping Wang (ORCID: https://orcid.org/0000-0003-4325-9939)
- Xiaojing Nie (ORCID: https://orcid.org/0000-0003-0130-6952)
Institutions
- Tsinghua University (CN)
Publication Details
- Journal
- Frontiers in Endocrinology
- Published
- 2025-12-19
- DOI
- https://doi.org/10.3389/fendo.2025.1586626
- Primary Topic
- Bone health and treatments
- Type
- article
- Field-Weighted Citation Impact
- 0.00