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临床试验/NCT01675089
NCT01675089已完成4 期

A Prospective and Randomized Trial of Zoledronic Acid to Prevent Bone Loss in the First Year After Kidney Transplantation

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
34
试验地点
1
主要终点
Differences in bone turnover

研究概览

简要总结

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

详细描述

For the treatment of osteoporosis in the general population, a number of drugs reduce BMD (bone mineral density) loss and the rate of incident fractures. For instance, bisphosphonates improve BMD, reduce hip fracture rates and decrease mortality in post-menopausal women. Because of lack of data on safety and an increased risk of adverse effects, the use of these drugs is controversial in patients with chronic kidney disease (CKD) and abnormalities of PTH or vitamin D, an estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m² (CKD stages 4 and 5) and after transplantation. The efficacy of short and long term bisphosphonate treatment after kidney transplantation has been examined; however, histomorphometric and fracture rate reduction data are lacking.

The purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • All adult kidney transplant recipients who were stable perioperative and able to return for regular follow-up

排除标准

  • Glomerular filtration rate < 30 ml/min/1.73m² one week after transplantation
  • Previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)

研究组 & 干预措施

Zoledronic acid

Experimental

Intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement.

干预措施: Zoledronic acid (Drug)

结局指标

主要结局

Differences in bone turnover

时间窗: 1 year

Bone histomorphometric data will be analyzed at baseline and after 1 year of kidney transplantation.

次要结局

  • Bone microarchitecture(1 year)
  • Changes in Bone Mineral Density(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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