Summary

Our study examined renal function change in older adults with osteoporosis, treated with zoledronic acid. Risk of nephrotoxicity was low. Future studies are needed to evaluate use of zoledronic acid in patients with a CCr < 35 mL/min, as patients may be inappropriately excluded from its use.

Introduction

Zoledronic acid (ZA) is used for the treatment of osteoporosis (OP). Renal impairment is a known risk factor for the rare occurrence of nephrotoxicity after ZA infusions, leading to use being contraindicated below creatinine clearance (CCr) of 35 mL/min. Our aims are to examine changes in serum creatinine (SCr) after infusions, capture frequency of acute kidney injury (AKI), and describe baseline kidney function estimates in adults 75 years and older being treated for OP.

Methods

This was a retrospective, cross-sectional, pre-post analysis that examined change in SCr before and after ZA infusions. The primary outcome was assessed using a paired Student t-test. Incidence of AKI within 1 year following infusions was noted and patient-specific factors were collected.

Results

Five hundred fifty-eight ZA infusions in 327 patients met criteria. Mean SCr decreased by 0.01 mg/dL in the year following ZA infusions (p = 0.005). AKI occurred in 1.4% of patients and all had CCr > 45 mL/min. 4.5% of patients had CCr < 35 mL/min and none experienced an AKI.

Conclusion

There was no clinically relevant change in SCr after ZA infusions. Risk of nephrotoxicity was low and similar to risk seen in randomized trials occurring in younger patients. Kidney function estimates were dramatically lower using the Cockcroft-Gault (CG) equation in comparison to CKD-EPI. We believe use of the CG equation in this population may be inappropriately limiting our ability to use ZA for treatment of OP in older adults but more evidence is necessary.

中文翻译：

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唑来膦酸治疗 75 岁及以上成人骨质疏松症的肾脏安全性

概括

我们的研究检查了用唑来膦酸治疗的老年骨质疏松症患者的肾功能变化。肾毒性风险低。未来的研究需要评估唑来膦酸在 CCr < 35 mL/min 的患者中的使用，因为患者可能被不恰当地排除在其使用之外。

介绍

唑来膦酸（ZA）用于治疗骨质疏松症（OP）。肾功能损害是 ZA 输注后罕见发生肾毒性的已知风险因素，导致肌酐清除率 (CCr) 低于 35 mL/min 时禁用。我们的目标是检查输注后血清肌酐 (SCr) 的变化，捕捉急性肾损伤 (AKI) 的频率，并描述接受 OP 治疗的 75 岁及以上成年人的基线肾功能估计值。

方法

这是一项回顾性、横断面、事后分析，检查了 ZA 输注前后 SCr 的变化。使用配对学生t检验评估主要结果。记录输注后 1 年内 AKI 的发生率，并收集患者特异性因素。

结果

327 名患者的 558 次 ZA 输注符合标准。在 ZA 输注后的一年中，平均 SCr 下降了 0.01 mg/dL ( p  = 0.005)。AKI 发生在 1.4% 的患者中，并且所有患者的 CCr > 45 mL/min。4.5% 的患者 CCr < 35 mL/min，没有人发生 AKI。

结论

ZA 输注后 SCr 没有临床相关变化。肾毒性风险较低，与年轻患者随机试验中的风险相似。与 CKD-EPI 相比，使用 Cockcroft-Gault (CG) 方程的肾功能估计值显着降低。我们认为在该人群中使用 CG 方程可能会不恰当地限制我们使用 ZA 治疗老年人 OP 的能力，但需要更多证据。