ArticleTherapeutics and clinical risk management2019
Evaluation of medication-related osteonecrosis of the jaw using the Japanese Adverse Drug Event Report database.
Article in Therapeutics and clinical risk management, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed, 17 citations in OpenAlex.
- Gastrointestinal adverse events associated with axitinib: pharmacovigilance analysis of the Japanese adverse drug event report database.Pharmacological reports : PR · 2026Article
- Disproportionality analysis of hematologic adverse events associated with trastuzumab deruxtecan using the Japanese pharmacovigilance database.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Article
- Disproportionality Analysis of Pulmonary Adverse Events Associated with Trastuzumab Deruxtecan Using the Japanese Adverse Drug Event Report Database.Clinical drug investigation · 2025Observational
- Article
- 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.Drugs - real world outcomes · 2022Article
- Medication Related Osteonecrosis of the Jaw: 2021 Position Statement of the Korean Society for Bone and Mineral Research and the Korean Association of Oral and Maxillofacial Surgeons.Journal of bone metabolism · 2021Article
- Review and Update of the Risk Factors and Prevention of Antiresorptive-Related Osteonecrosis of the Jaw.Endocrinology and metabolism (Seoul, Korea) · 2021Review
- A multicenter observational study on Medication-Related Osteonecrosis of the Jaw (MRONJ) in advanced cancer and myeloma patients of a cancer network in North-Western Italy.Medicina oral, patologia oral y cirugia bucal · 2021Observational
- Comparison of Adverse Event Profiles of Tumor Necrosis Factor-Alfa Inhibitors: Analysis of a Spontaneous Reporting Database.Therapeutics and clinical risk management · 2020Article
- Mitigating osteonecrosis of the jaw (ONJ) through preventive dental care and understanding of risk factors.Bone research · 2020Review
- Comparison of Safety Profiles of New Oral Anticoagulants with Warfarin Using the Japanese Spontaneous Reporting Database.Clinical drug investigation · 2019Article
- Comprehensive Analysis of Proteinuria and Nephrotic Syndrome Using the Japanese Adverse Drug Event Reporting Database.In vivo (Athens, Greece)Article
- Drug-induced Aseptic Meningitis: Pharmacovigilance Analysis of Japanese Adverse Event Reporting Database.In vivo (Athens, Greece)Article
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8 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBisphosphonates (BPs) and denosumab are widely used to treat osteoporosis and complications associated with bone metastases. However, medication-related osteonecrosis of the jaw (MRONJ) is a serious problem.
objectiveThe objective of this study was to evaluate the frequency, outcome, and characteristics of patients with drug-induced MRONJ.
methodsRetrospective pharmacovigilance disproportionality analysis was conducted using the Japanese Adverse Drug Event Report (JADER) database from the Pharmaceuticals and Medical Devices Agency. Adverse event reports submitted to JADER between 2004 and 2017 were analyzed, and the reporting odds ratio (ROR) was calculated.
resultsAmong the BPs that cause MRONJ, zoledronate was the most common; therefore, we compared the characteristics of cases of MRONJ induced by zoledronate with those induced by denosumab. Among the 3,875 (68.1% women) cases of MRONJ, zoledronate-related MRONJ accounted for 1,283 (56.0% women) and denosumab-related MRONJ accounted for 322 (55.3% women). MRONJ was more frequent after 70 years of age regardless of the use of either zoledronate or denosumab; onset occurred after 1 year from the denosumab treatment, but it is unknown when onset occurred after zoledronate treatment. The outcomes for MRONJ were poor, with 406 reports on zoledronate (31.6%) and 152 reports on denosumab (47.2%) demonstrating nonrecovery. Zoledronate (ROR: 319.3, 95% CI: 296.0-344.4) had the highest ROR among BP agents. Denosumab had a high ROR (ROR: 155.2, 95% CI: 136.5-176.3). Zoledronate and denosumab were used in similar patient backgrounds, and their use resulted in a similar frequency of MRONJ.
conclusionThe findings of this comprehensive evaluation of MRONJ using the JADER database will be helpful for prescribing medications to elderly patients.
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