ArticleJournal of pharmaceutical health care and sciences2015
Analysis of the time-to-onset of osteonecrosis of jaw with bisphosphonate treatment using the data from a spontaneous reporting system of adverse drug events.
Article in Journal of pharmaceutical health care and sciences, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 75 citations in OpenAlex.
- Interventions for managing medication-related osteonecrosis of the jaw.The Cochrane database of systematic reviews · 2022Pooled it
- Interventions for managing medication-related osteonecrosis of the jaw.The Cochrane database of systematic reviews · 2017Pooled it
- Comparative Effects of Minodronate and Alendronate on Low Back Pain in Postmenopausal Osteoporosis and Age Influence: A Head-to-Head, Randomized Clinical Trial.Clinical interventions in aging · 2025Trial
- Incidence of osteonecrosis of the jaw in Japanese osteoporosis patients taking minodronic acid.Journal of bone and mineral metabolism · 2019Trial
- Integrating pharmacovigilance and machine learning: bleeding signal detection and risk prediction for oral anticoagulants in cancer patients.Research and practice in thrombosis and haemostasis · 2026Article
- Evaluating adverse events of antibacterials in infants: insights from FDA adverse event reporting system (FAERS) data.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Immunotherapy Safety in Thymic Epithelial Tumors: Disproportionality Analysis of the Food and Drug Administration Adverse Event Reporting System.JMIR cancer · 2026Article
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- Evaluating adverse events of pegvaliase-pqpz in phenylketonuria treatment: A comprehensive safety assessment.SAGE open medicine · 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
- Article
- Adverse drug reactions to atezolizumab in combination with bevacizumab in hepatocellular carcinoma patients: an analysis of the food and drug administration adverse event reporting system database.Frontiers in pharmacology · 2025Article
- Article
- Adverse Event Profiles of Adalimumab in Children: A Disproportionality Analysis.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Adverse Event Profiles of the Third-Generation Aromatase Inhibitors: Analysis of Spontaneous Reports Submitted to FAERS.Biomedicines · 2024Article
- Tumor lysis syndrome signal with the combination of encorafenib and binimetinib for malignant melanoma: a pharmacovigilance study using data from the FAERS database.Frontiers in pharmacology · 2024Article
- A real-world pharmacovigilance study of drug-induced QT interval prolongation: analysis of spontaneous reports submitted to FAERS.Frontiers in cardiovascular medicine · 2024Article
- Antihypertensive drug-associated adverse events in osteoarthritis: a study of a large real-world sample based on the FAERS database.Frontiers in pharmacology · 2024Article
- Analysis of the risk of oncological adverse events associated with infliximab in combination with azathioprine compared to monotherapy: insights from the FAERS database.Frontiers in pharmacology · 2024Article
Corrections and comments
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Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBisphosphonates (BPs) are potent antiresorptive agents used to treat osteoporosis and the complications associated with malignant bone metastasis. The aim of this study was to evaluate the incidence of bisphosphonate-related osteonecrosis of the jaw (BRONJ) using the Japanese Adverse Drug Event Report (JADER) database. In particular, we focused on the time-to-onset profile of BRONJ.
findingsWe analyzed reports of BRONJ in the JADER database and calculated the reporting odds ratio (ROR) of BPs potentially associated with BRONJ. We applied the weibull shape parameter to time-to-event data in JADER. The drugs selected for this investigation were seven BPs approved in Japan (alendronate [intraveneous, I.V.], pamidronate, and zoledronate as I.V. BPs; and alendronate (oral), etidronate, minodronate, and risedronate as oral BPs). We analyzed reports of BRONJ events associated with BPs in the JADER database from April 2004 to November 2014. The median value of BRONJ cases caused by alendronate (I.V.), pamidronate, zoledronate, alendronate (oral), etidronate, minodronate, and risedronate were 1342, 812, 486, 863, 1461, 432, and 730 days, respectively. The lower 95 % confidence interval of the Weibull-shape parameter β for I.V. BPs (pamidronate and zoledronate) exceeded 1. The risk of BRONJ with I.V. BPs increased over time.
conclusionThus, the incidence of BRONJ with BP treatment should be closely monitored for a 3-year period. Further studies are required to draw conclusions, and we believe that this information about BRONJ induced by BPs will prove beneficial to patients and pharmacists.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.