Effects of Denosumab on Fracture and Bone Mineral Density by Level of Kidney Function
Effects of Denosumab on Fracture and Bone Mineral Density by Level of Kidney Function
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DOI：
10.1002/jbmr.403
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发表时间：
2011-08-01
影响因子：
6.2
通讯作者：
Miller, Paul D.
中科院分区：
文献类型：
--
作者：
Jamal, Sophie A.;Ljunggren, Osten;Miller, Paul D.
骨质疏松症和慢性肾脏病(CKD)的发病率都随着年龄的增长而增加，但在肾功能受损的情况下治疗骨质疏松症的数据却很少。我们在每6个月一次的骨质疏松骨折复位评估(FREE)研究中，对地诺单抗(DMAb)的有效性和安全性进行了检测。我们使用Cockcroft-Gault估计肌酐清除量(EGFR)，并使用修改的国家肾脏基金会CKD分类方法对肾功能水平进行分类。我们检查了接受DMAb或安慰剂治疗的受试者36个月的骨折发生率、骨密度(BMD)、血钙和肌酐的变化，以及不良事件的发生率，按肾功能水平分层。我们使用亚组相互作用项来确定EGFR的治疗效果是否存在差异。大多数(93%)女性是白人，平均年龄为72.3+/-5.2岁；73名女性的EGFR在15-29ml/min之间；2817名女性的EGFR在30-59ml/min之间；4069名女性的EGFR在60-89ml/min之间；842名女性的EGFR在90ml/min或以上。无一例为5期CKD。骨折风险的降低和所有部位骨密度的变化均有利于DMAb。亚组交互作用的治疗检验无统计学意义，表明治疗效果不因肾功能而异。两组间肌酐和钙的变化以及不良事件的发生率相似，且不受肾功能水平的影响。结论是，DMAb在降低骨折风险方面是有效的，并且与肾功能受损患者不良事件的增加无关。(C)2011年美国骨与矿物研究学会。
The incidences of osteoporosis and chronic kidney disease (CKD) both increase with increasing age, yet there is a paucity of data on treatments for osteoporosis in the setting of impaired kidney function. We examined the efficacy and safety of denosumab (DMAb) among subjects participating in the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6Months (FREEDOM) Study. We estimated creatinine clearance (eGFR) using Cockcroft-Gault and classified levels of kidney function using the modified National Kidney Foundation classification of CKD. We examined incident fracture rates; changes in bone mineral density (BMD), serum calcium, and creatinine; and the incidence of adverse events after 36 months of follow-up in subjects receiving DMAb or placebo, stratified by level of kidney function. We used a subgroup interaction term to determine if there were differences in treatment effect by eGFR. Most (93%) women were white, and the mean age was 72.3 +/- 5.2 years; 73 women had an eGFR of 15 to 29mL/min; 2817, between 30 to 59mL/min; 4069, between 60 to 89mL/min, and 842 had an eGFR of 90mL/min or greater. None had stage 5 CKD. Fracture risk reduction and changes in BMD at all sites were in favor of DMAb. The test for treatment by subgroup interaction was not statistically significant, indicating that treatment efficacy did not differ by kidney function. Changes in creatinine and calcium and the incidence of adverse events were similar between groups and did not differ by level of kidney function. It is concluded that DMAb is effective at reducing fracture risk and is not associated with an increase in adverse events among patients with impaired kidney function. (C) 2011 American Society for Bone and Mineral Research.