Shigematsu Takashi, Muraoka Ryoichi, Sugimoto Toshitsugu, Nishizawa Yoshiki
Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, Japan.
Data Science Group, Clinical Development Department, EA Pharma Co., Ltd, Tokyo, Japan.
BMC Nephrol. 2017 Feb 15;18(1):66. doi: 10.1186/s12882-017-0478-9.
The clinical effect of bisphosphonate treatment has not been clearly evaluated by kidney function in Japanese Chronic Kidney Disease (CKD) patients with osteoporosis. This study analyzed the data from three risedronate Japanese phase III trials. The clinical effect of risedronate therapy was evaluated in CKD patients with osteoporosis.
The Japanese clinical trials involved 852 subjects who received risedronate (2.5 mg once daily or 17.5 mg once weekly) and whose estimated glomerular filtration rate (eGFR) were calculable and at ≥ 30 mL/min. The subjects were divided into subgroups according to the eGFR level: ≥ 90 mL/min/1.73 m, ≥ 60 to < 90 mL/min/1.73 m, ≥ 30 to < 60 mL/min/1.73 m. Lumbar spine bone mineral density (BMD), bone turnover markers (BTMs) and adverse events were evaluated at 48 weeks.
Adverse event incidence was similar among three subgroups. There was also no exacerbation of impaired kidney function associated with risedronate administration in the subjects with eGFR above 30 mL/min/1.73 m. Risedronate administration induced a significant increase in lumbar spine BMD and significant inhibition of BTMs in three subgroups.
The risedronate therapy showed similar clinical effects in CKD patients with osteoporosis compared to those without CKD.
在日本慢性肾脏病（CKD）合并骨质疏松症的患者中，双膦酸盐治疗的临床效果尚未通过肾功能得到明确评估。本研究分析了三项利塞膦酸钠日本III期试验的数据。对CKD合并骨质疏松症患者的利塞膦酸钠治疗的临床效果进行了评估。
日本的临床试验纳入了852名接受利塞膦酸钠治疗（每日一次2.5mg或每周一次17.5mg）且估算肾小球滤过率（eGFR）可计算且≥30mL/min的受试者。根据eGFR水平将受试者分为亚组：≥90mL/min/1.73m²、≥60至<90mL/min/1.73m²、≥30至<60mL/min/1.73m²。在48周时评估腰椎骨密度（BMD）、骨转换标志物（BTMs）和不良事件。
三个亚组的不良事件发生率相似。在eGFR高于30mL/min/1.73m²的受试者中，也没有发现与利塞膦酸钠给药相关的肾功能损害加重情况。利塞膦酸钠给药使三个亚组的腰椎BMD显著增加，并显著抑制了BTMs。
与无CKD的患者相比，利塞膦酸钠治疗在CKD合并骨质疏松症的患者中显示出相似的临床效果。
