ArticleFrontiers in endocrinology2025
Risk factors for denosumab-related osteonecrosis of the jaw: a pharmacovigilance study using the U.S. FDA adverse event reporting system database.
Article in Frontiers in endocrinology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
- Bone-modifying therapy in multiple myeloma: a comprehensive review.Frontiers in oncology · 2026Review
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Authors and funding
6 authors.
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Abstract
Objective: This study aims to comprehensively evaluate risk factors for denosumab-related osteonecrosis of the jaw (ONJ), focusing on dosage, concomitant medications, and patient demographics, to inform clinical decision-making and optimize therapeutic strategies. Methods: A retrospective pharmacovigilance analysis was conducted using data from the US FDA Adverse Event Reporting System (FAERS) spanning Q2-2010 to Q3 2024. Disproportionality analysis, logistic regression analysis, and time-to-onset analysis were employed to assess the association between denosumab use and ONJ. Key variables included dosage (60 mg Q6m Results: Among 7,689 denosumab-related ONJ cases, the 120 mg dose demonstrated markedly higher ONJ risk (reporting odds ratio [ROR] = 245.47 Conclusions: 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.
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