Masuda Soichiro, Fukasawa Toshiki, Matsuda Shuichi, Kawakami Koji
Department of Orthopedic Surgery, Kyoto City Hospital, and Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan (S.Masuda).
Department of Pharmacoepidemiology and Department of Digital Health and Epidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan (T.F.).
Ann Intern Med. 2025 Feb;178(2):167-176. doi: 10.7326/ANNALS-24-03237. Epub 2025 Jan 7.
Dialysis patients have high rates of fracture morbidity, but evidence on optimal management strategies for osteoporosis is scarce.
To determine the risk for cardiovascular events and fracture prevention effects with denosumab compared with oral bisphosphonates in dialysis-dependent patients.
An observational study that attempts to emulate a target trial.
A Japanese administrative claims database (April 2014 to October 2022).
Adults aged 50 years or older who have initiated denosumab or oral bisphosphonates for osteoporosis in dialysis-dependent patients.
The safety outcome was major adverse cardiac events (MACE). The effectiveness outcome was a composite of all fractures. Follow-up was 3 years.
A total of 1032 patients were identified (658 denosumab users and 374 oral bisphosphonate users). Overall average age was 74.5 years, and 62.9% were women. The weighted 3-year risk difference for MACE was 8.2% (95% CI, -0.2% to 16.7%), with a weighted 3-year risk ratio of 1.36 (CI, 0.99 to 1.87). The weighted 3-year risk difference for composite fractures was -5.3% (CI, -11.3% to -0.6%), and the weighted 3-year risk ratio was 0.55 (CI, 0.28 to 0.93).
Lack of clinical data on kidney or osteoporosis disease severity and cardiovascular or other metabolic risk with residual confounding. Safety outcomes did not include kidney end points.
It was estimated that, compared with oral bisphosphonates, denosumab lowered the risk for fractures by 45% and increased the risk for MACE by 36%. The estimates, however, are imprecise and need to be confirmed in future studies.
None.
透析患者骨折发病率较高，但关于骨质疏松症最佳管理策略的证据稀缺。
确定在依赖透析的患者中，与口服双膦酸盐相比，地诺单抗对心血管事件风险和骨折预防效果的影响。
一项试图模拟目标试验的观察性研究。
日本行政索赔数据库（2014年4月至2022年10月）。
年龄在50岁及以上、已开始在依赖透析的患者中使用地诺单抗或口服双膦酸盐治疗骨质疏松症的成年人。
安全结局为主要不良心脏事件（MACE）。有效性结局为所有骨折的复合情况。随访3年。
共识别出1032例患者（658例使用地诺单抗，374例使用口服双膦酸盐）。总体平均年龄为74.5岁，62.9%为女性。MACE的加权3年风险差异为8.2%（95%CI，-0.2%至16.7%），加权3年风险比为1.36（CI，0.99至1.87）。复合骨折的加权3年风险差异为-5.3%（CI，-11.3%至-0.6%），加权3年风险比为0.55（CI，0.28至0.93）。
缺乏关于肾脏或骨质疏松症疾病严重程度以及心血管或其他代谢风险的临床数据，存在残余混杂因素。安全结局未包括肾脏终点。
据估计，与口服双膦酸盐相比，地诺单抗使骨折风险降低了45%，使MACE风险增加了36%。然而，这些估计并不精确，需要在未来研究中得到证实。
无。
