ArticleDrugs - real world outcomes2022
Osteonecrosis of the Jaw Caused by Denosumab in Treatment-Naïve and Pre-Treatment with Zoledronic Acid Groups: A Time-to-Onset Study Using the Japanese Adverse Drug Event Report (JADER) Database.
Article in Drugs - real world outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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10 citing papers in PubMed, 14 citations in OpenAlex.
- Disproportionality Analysis and Timing of Drug-Associated Guillain-Barré Syndrome Onset Based on the Japanese Adverse Drug Event Report Database.Pharmaceuticals (Basel, Switzerland) · 2026Article
- [Expert consensus on perioperative management of tooth extraction in patients receiving denosumab therapy].Hua xi kou qiang yi xue za zhi = Huaxi kouqiang yixue zazhi = West China journal of stomatology · 2026Article
- Efficacy of concentrated growth factors preventing medication-related osteonecrosis of the jaw following tooth extraction in patients on intravenous bisphosphonates: A randomized controlled trial.Journal of dental sciences · 2026Article
- [Medication-related osteonecrosis of the jaw (MRONJ) during the treatment of cancer patients].Magyar onkologia · 2025Review
- Development of a Medication-Related Osteonecrosis of the Jaw Prediction Model Using the FDA Adverse Event Reporting System Database and Machine Learning.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Analysis of Bevacizumab-Induced Gastrointestinal Perforation Using the Japanese Adverse Drug Event Report Database.Cureus · 2025Article
- Risk factors for denosumab-related osteonecrosis of the jaw: a pharmacovigilance study using the U.S. FDA adverse event reporting system database.Frontiers in endocrinology · 2025Article
- Differences in the Adverse Event Profiles of Sodium-Glucose Cotransporter 2 Inhibitors used in Patients with Diabetes Mellitus and Heart Failure: An Analysis Using the Japanese Adverse Drug Event Report Database.Clinical drug investigation · 2024Article
- Examination of Risk Factors and Expression Patterns of Atypical Femoral Fractures Using the Japanese Adverse Drug Event Report Database: A Retrospective Pharmacovigilance Study.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Possibility of Multiple Drug-Drug Interactions in Patients Treated with Statins: Analysis of Data from the Japanese Adverse Drug Event Report (JADER) Database and Verification by Animal Experiments.International journal of medical sciences · 2022Article
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Authors and funding
13 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundMedication-related osteonecrosis of the jaw is a serious adverse event associated with bone-modifying agents, such as injectable bisphosphonate (zoledronic acid) and the anti-receptor activator of nuclear factor-κB ligand antibody (denosumab).
objectiveThis study aims to evaluate and compare the time-to-onset profile for medication-related osteonecrosis of the jaw associated with denosumab between treatment-naïve (naïve group) and pre-treatment with zoledronic acid (post-zoledronic acid group) patients using the Japanese Adverse Drug Event Report database.
methodsMedication-related osteonecrosis of the jaw was defined according to the Medical Dictionary for Regulatory Activities. The medication-related osteonecrosis of the jaw onset profiles were evaluated using the Weibull shape parameter and the log-rank test.
resultsThe Japanese Adverse Drug Event Report database contains 632,409 reports published between April 2004 and March 2020. In the time-to-onset analysis, after extracting the combinations with complete information for the treatment start date and the medication-related osteonecrosis of the jaw onset date, 272 reports of the naïve group and 86 reports of the post-zoledronic acid group were analyzed. The median onset in the naïve and post-zoledronic acid groups was 487.0 (25-75%: 274.0-690.8) and 305.5 (25-75%: 158.3-508.5) days, respectively. Medication-related osteonecrosis of the jaw occurred earlier in the post-zoledronic acid group than in the naïve group, and the log-rank test demonstrated a significant difference in their time transitions (p < 0.0001).
conclusionsThe results indicated a risk of medication-related osteonecrosis of the jaw in naïve and post-zoledronic acid groups and a shorter onset time in the latter than in the former. Thus, healthcare professionals should take the early risk of medication-related osteonecrosis of the jaw into account when switching patients from zoledronic acid to denosumab treatment.
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