■ 学会名
62nd ERA Congress

■ 発表日
2025/06/05

■ 筆頭演者
Tatsunori Toida¹,²
1) Kyushu University of Medical Science, Nobeoka-city, Miyazaki, Japan,
2) Department of Clinical Epidemiology, Graduate School of Medicine, Fukushima Medical University, Fukushima, Japan

■ 共同演者
Tatsuyoshi Ikenoue³, Ryoji Tominaga²,⁴, Ryohei Inenaga²,⁵, Akihito Fujita⁶, Masataka Taguri⁶, Noriaki Kurita²
2) Department of Clinical Epidemiology, Graduate School of Medicine, Fukushima Medical University, Fukushima, Japan
3) Data Science and AI Innovation Research Promotion Center, Shiga University, Hikone-city, Shiga, Japan
4) Iwai Orthopaedic Hospital, Tokyo, Japan
5) Department of Nephrology, Shin-Yurigaoka General Hospital, Kanagawa, Japan
6) Department of Health Data Science, Tokyo Medical University, Tokyo, Japan

■ 発表形態
Poster

■ 要旨
Background and Aims: The comparative cardiovascular safety and fracture prevention effectiveness of denosumab versus bisphosphonates in patients undergoing dialysis has been reported previously. However, evidence regarding medication-related osteonecrosis of the jaw (MRONJ) and clinical fractures, particularly recurrent fractures, remains limited. This study aimed to evaluate the comparative safety and effectiveness of denosumab versus bisphosphonates among patients on maintenance haemodialysis.
Methods: We conducted a cohort study emulating a target trial using the DeSC Healthcare Comprehensive Japanese Administrative Claims Database. Patients receiving maintenance haemodialysis with osteoporosis or fragility fractures who newly initiated denosumab or bisphosphonates between March 2019 and August 2023 were included. The primary safety outcome was MRONJ, while effectiveness outcomes were first and recurrent clinical fractures. Cox proportional hazards models were used to estimate hazard ratios (HRs) for MRONJ and first fractures, and the Anderson–Gill model was applied for recurrent fractures. Inverse probability of treatment weighting was used to adjust for confounding.
Results: A total of 2,119 patients were analysed (denosumab: 673; bisphosphonates: 1,446). MRONJ incidence was rare but numerically higher with denosumab (HR 2.16, 95% CI 0.62–7.51). Denosumab was associated with a significantly lower risk of first fractures (HR 0.70, 95% CI 0.49–1.00) and recurrent fractures (HR 0.68, 95% CI 0.48–0.97).
Conclusion: In haemodialysis patients, denosumab offers superior fracture prevention but may increase MRONJ risk, requiring careful clinical consideration.