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临床试验/NCT03082742
NCT03082742Unknown不适用

The Effect of Thiazide and Loop Diuretic on Mineral and Bone Disorder in Chronic Kidney Disease Patients

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
52
试验地点
1
主要终点
Parathyroid hormone (PTH) level.

研究概览

简要总结

Chronic kidney disease (CKD) patients often have associated systemic hypertension due to volume retention, as one of the mechanisms, therefore the use of diuretics is widespread in this population. One of the major complications of CKD is mineral and bone metabolism disorder (CKD-MBD), which include changes in the levels of calcium, phosphorus, vitamin D deficiency, increased circulating levels of fibroblast growth factor (FGF-23) and parathyroid hormone (PTH). These alterations are responsible for fractures, cardiovascular disease and mortality among patients with CKD. According to diuretic mechanism of action, sometimes increasing serum calcium (in the case of furosemide), sometimes decreasing it (in the case of thiazide), it is expected that the serum calcium may be altered, even within the range of normality, with consequent impact on the levels of PTH. Although most studies have shown that the use of thiazide diuretics decreases the risk of fractures, some showed the opposite. Similarly, although most studies have shown increased risk of fracture in association to loop diuretics use, some have failed in demonstrated this outcome. Only one study, a cohort study in a population of CKD, showed that furosemide was directly related to increased calciuria and PTH levels and the use of thiazide, in turn, showed completely opposite effect. However, certain issues are still not completely solved, for example, the interference of renal function itself on calciuria. It is possible that calciuria is not a so simple explanation that justifies the PTH levels changes, as no correlation was seen between calciuria and PTH levels. Better understanding of the exact relationship between the use of diuretics and the impact on CKD-MBD may be an alternative intervention, easily accessible and relatively inexpensive. The purpose of this study is to evaluate the impact of diuretic, specifically hydrochlorothiazide and furosemide, on bone architecture and mineral metabolism.

详细描述

This is a prospective randomized study to test the effects of thiazide and furosemide in bone parameters, which will be assessed by peripheral micro-tomography at baseline and 12 months later. The role of calciuria in these possible changes will be tested.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Estimated Glomerular Filtration Rate (calculated by CKD-EPI) between 30 and 60 ml/min

排除标准

  • Diabetes;
  • chronic use of: steroid, bisphosphonates and calcium carbonate

研究组 & 干预措施

Furosemide

Active Comparator

Use of Furosemide, 40mg (1 tablet) per day, over 12 months

干预措施: Furosemide (Drug)

Hydrochlorothiazide

Active Comparator

Use of Hydrochlorothiazide, 25mg (1 tablet) per day, over 12 months

干预措施: Hydrochlorothiazide (Drug)

结局指标

主要结局

Parathyroid hormone (PTH) level.

时间窗: 12 months

Bone metabolism

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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