跳至主要内容
临床试验/NCT00302484
NCT00302484Unknown不适用

Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2002年4月最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
96
试验地点
2
主要终点
first bone fracture or death within 24 months after liver transplantation

研究概览

简要总结

Patients with a terminal chronic liver disease have a disordered bone metabolism resulting in a higher risk of falling ill with osteoporosis. Although liver transplantation restores liver function, immunosuppressive therapy (especially corticosteroids) after transplantation increases again the risk of osteoporosis and bone fragility. Zoledronate, a bisphosphonate, slows down the destruction of bone. The purpose of this study is to determine whether bisphosphonates are effective in the prevention of osteoporosis following immunosuppressive therapy after liver transplantation.

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
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

  • primary liver transplantation
  • retransplantation within two weeks
  • written informed consent
  • Age ≥ 18 years

排除标准

  • chronic kidney disease:
  • Creatinine Clearance < 35 ml/min or Serum Creatinine > 2,5 mg/dl
  • known hypersensitivity to Zoledronate, or any of the recipients of the drug
  • bone specific medication (Bisphosphonate, Fluoride, Calcitonin) within the last three months before liver transplantation

结局指标

主要结局

first bone fracture or death within 24 months after liver transplantation

次要结局

  • bone mineral density (pre-transplant, 6 and 12 months post-transplant)
  • serum biochemical bone markers (osteocalcin, alkaline phosphatase, parathyroid hormone)
  • histomorphometric measurements of transiliacal bone biopsies (intraoperative, 6 months post-transplant)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验