| アブストラクト | INTRODUCTION: Comparative effectiveness of denosumab versus bisphosphonates for overall fracture risk and medication-related osteonecrosis of the jaw (MRONJ) in patients on hemodialysis remains unclear. We compared fracture outcomes and MRONJ using linked medical-dental claims. MATERIALS AND METHODS: We used the DeSC Healthcare Database to identify patients on hemodialysis with osteoporosis or prior fragility fractures prescribed denosumab or bisphosphonates from March 2015 to August 2022. Separate prevalent-user (ongoing users) and new-user (treatment initiators) cohorts were constructed. The primary outcome was all clinical fractures, including first and subsequent events; secondary outcomes were first clinical, hip, vertebral, and other fractures. The safety outcome was first MRONJ. IPTW-weighted Cox models estimated hazard ratios with 95% confidence intervals. RESULTS: Among 2379 prevalent-user and 1024 new-user records, mean age was 79 years, and 30-40% had a history of clinical fractures. In the prevalent-user cohort, denosumab was associated with a lower incidence of all clinical fractures than bisphosphonates. Point estimates for first-fracture outcomes generally favored denosumab but were imprecise. In the new-user cohort, the point estimates were generally similar in direction, but the results were not statistically significant. First MRONJ incidence was 0.31 and 0.65 per 100 person-years in the bisphosphonate and denosumab groups, respectively, without statistical significance. CONCLUSION: In the prevalent-user cohort, denosumab was associated with a lower incidence of all clinical fractures than bisphosphonates, whereas first-fracture associations and the new-user analysis were imprecise. These findings and the low incidence of MRONJ may inform shared decision-making regarding antiresorptive therapies. |
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| 投稿者 | Toida, Tatsunori; Kurita, Noriaki; Fujita, Akihito; Tominaga, Ryoji; Inanaga, Ryohei; Taguri, Masataka; Ikenoue, Tatsuyoshi |
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| 組織名 | Division of Nephrology, Toho University Ohashi Medical Center, Meguro-ku, Tokyo,;Japan.;Department of Clinical Epidemiology, Graduate School of Medicine, Fukushima;Medical University, Fukushima City, Fukushima, Japan.;Medical University, Fukushima City, Fukushima, Japan. kuritanoriaki@gmail.com.;Department of Preventive Medicine, Tokai University School of Medicine, 143;Shimokasuya, Isehara City, Kanagawa, 259-1143, Japan. kuritanoriaki@gmail.com.;Department of Innovative Research and Education for Clinicians and Trainees;(DiRECT), Fukushima Medical University Hospital, Fukushima City, Fukushima,;Japan. kuritanoriaki@gmail.com.;Department of Health Data Science, Tokyo Medical University, Shinjuku-ku, Tokyo,;Iwai Orthopaedic Hospital, Edogawa-ku, Tokyo, Japan.;Department of Nephrology, Shin-Yurigaoka General Hospital, Kawasaki, Kanagawa,;Department of Public Health, Miyazaki University School of Medicine, Miyazaki;City, Miyazaki, Japan.;Data Science and AI Innovation Research Promotion Center, Shiga University,;Hikone, Shiga, Japan.;Human Health Science, Kyoto University Graduate School of Medicine, Kyoto, Kyoto, |
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