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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a report, two men aged 79 years and 66 years were described, of whom the 79-year-old man developed osteonecrosis of the jaw (ONJ) following treatment with zoledronic acid, and radium-223-chloride for metastases of prostate cancer. Whereas, the 66-year-old man developed ONJ following treatment with zoledronic acid, and worsening of the ONJ following treatment with radium-223-chloride for metastases of prostate cancer [not all dosages and routes stated; durations of treatments to reactions onsets not stated].
Case 1: The man, who had prostate cancer with bone metastases, started receiving second-line therapy with zoledronic acid 4mg and abiraterone acetate in May 2013. Zoledronic acid was stopped in September 2014. Thereafter, he received various treatments, which were stopped...
- Dionisi V, et al. Use of Radium-223 Dichloride in Patients With Osteonecrosis of the Jaw Induced by Zoledronic Acid: Report of 2 Cases. Clinical Genitourinary Cancer 17: e612-e617, No. 3, Jun 2019. Available from: URL: http://doi.org/10.1016/j.clgc.2019.03.002 - Italy