Miho Ishimaru1, Sachiko Ono2, Kojiro Morita3, Hiroki Matsui4, Yasuhiro Hagiwara5, Hideo Yasunaga6. 1. Assistant Professor, Department of Health Services Research, Faculty of Medicine, University of Tsukuba. Electronic address: ishimaru.miho.kf@u.tsukuba.ac.jp. 2. Project Lecturer, Department of Eat-loss Medicine, Graduate School of Medicine, The University of Tokyo, Bunkyoku, Tokyo, Japan. 3. Project Lecturer, Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Bunkyoku, Tokyo, Japan. 4. Assistant Professor, Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Bunkyoku, Tokyo, Japan. 5. Assistant Professor, Department of Biostatistics, Graduate School of Medicine, The University of Tokyo, Bunkyoku, Tokyo, Japan. 6. Professor, Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, Bunkyoku, Tokyo, Japan.
Abstract
PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is a rare but severe adverse event of antiresorptive agents. However, the precise prevalence and factors associated with the development of MRONJ remain unknown. The present study was performed to describe the prevalence, incidence rate, and risk factors of developing MRONJ. METHODS: We conducted a population-based retrospective cohort study using the National Database of Health Insurance, an administrative claims database of all patients in Japan. We identified patients who newly began using antiresorptive drugs from April 2015 to December 2018. The primary outcome was the development of MRONJ. We calculated the prevalence and incidence rate of MRONJ and performed a time-dependent Cox proportional hazard regression analysis to examine risk factors for developing MRONJ. RESULTS: We identified 2,819,310 patients who newly used antiresorptive drugs during the study period. Of these patients, 2,664,104 (94.5%) had osteoporosis and 155,206 had cancer. Among the patients with osteoporosis, 1,603 (0.06%) developed MRONJ; the incidence rate was 22.9 per 100,000 person-years. Among the patients with cancer, 2,274 (1.47%) developed MRONJ; the incidence rate was 1,231.7 per 100,000 person-years. The occurrence of MRONJ was associated with poor oral conditions (including tooth extraction), age, male sex, drug type, concomitant drug use, comorbidities, cancer type, and geographic location. CONCLUSIONS: The overall prevalence and incidence rate were low, but they were still higher than those in previous studies. Poor oral conditions were more closely related to the development of MRONJ than other factors. These findings suggest that improving poor oral hygiene may be essential to prevent MRONJ.
PURPOSE: Medication-related osteonecrosis of the jaw (MRONJ) is a rare but severe adverse event of antiresorptive agents. However, the precise prevalence and factors associated with the development of MRONJ remain unknown. The present study was performed to describe the prevalence, incidence rate, and risk factors of developing MRONJ. METHODS: We conducted a population-based retrospective cohort study using the National Database of Health Insurance, an administrative claims database of all patients in Japan. We identified patients who newly began using antiresorptive drugs from April 2015 to December 2018. The primary outcome was the development of MRONJ. We calculated the prevalence and incidence rate of MRONJ and performed a time-dependent Cox proportional hazard regression analysis to examine risk factors for developing MRONJ. RESULTS: We identified 2,819,310 patients who newly used antiresorptive drugs during the study period. Of these patients, 2,664,104 (94.5%) had osteoporosis and 155,206 had cancer. Among the patients with osteoporosis, 1,603 (0.06%) developed MRONJ; the incidence rate was 22.9 per 100,000 person-years. Among the patients with cancer, 2,274 (1.47%) developed MRONJ; the incidence rate was 1,231.7 per 100,000 person-years. The occurrence of MRONJ was associated with poor oral conditions (including tooth extraction), age, male sex, drug type, concomitant drug use, comorbidities, cancer type, and geographic location. CONCLUSIONS: The overall prevalence and incidence rate were low, but they were still higher than those in previous studies. Poor oral conditions were more closely related to the development of MRONJ than other factors. These findings suggest that improving poor oral hygiene may be essential to prevent MRONJ.