NCT00302484Unknown不适用
Use of Bisphosphonates in the Treatment of Osteopathy After Liver Transplantation, a Prospective Randomised Study
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
- 否
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
研究点 (2)
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