The Effect Of The Bisphosphonate, Zoledronic Acid, On Bone Density In Liver Transplant Patients - A Prospective, Randomised, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- bone density
研究概览
简要总结
Following liver transplantation, rapid bone loss occurs, particularly within the first 6 months post-transplant. This may be associated with fractures, most notable vertebral. The ability to assess osteoporosis therapies in this system may provide useful information for osteoporosis management in general.
Hypotheses:
- That treatment with the bisphosphonate, zoledronate, at the time of liver transplantation and at 1 month post-transplantation will prevent the early transplant-related bone loss (measured by bone densitometry and biochemical bone markers at 3 months) seen in patients who are not treated with a bisphosphonate
- That continuing treatment with zoledronate at 3 monthly intervals for a total duration of 12 months will result in further improvements in bone density beyond that seen at 3 months
- That calcium and vitamin D (vit D) supplementation of liver transplant patients does not prevent marked bone loss following transplantation.
详细描述
This study is a prospective, randomised, double-blind, placebo-controlled clinical trial in liver transplant patients comparing therapy with the bisphosphonate, zoledronate, to patients who do not receive bisphosphonate therapy. All groups will receive calcium and vit D supplementation from the time patients are listed for transplantation and for 12 months post-transplantation. Recruited subjects will be 17 years or older (ie adult in terms of consent requirements).
The study groups comprise:
Group 1: Zoledronate plus calcium and vit D supplementation
Zoledronate 4 mg will be administered by intravenous infusion (details below) at baseline (within 72 h of liver transplantation), followed by zoledronate 4 mg infused as outlined below at 1, 3, 6 and 9 months post-transplantation PLUS calcium 600mg daily (Caltrate, one tablet) and ergocalciferol 1000 IU daily (Ostelin, one capsule) for 12 months post-transplantation.
Group 2: Placebo plus calcium and vit D supplementation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 17 years of age
排除标准
- •Concurrent treatment, or within the past 12 months, with drugs known to affect bone metabolism
- •Hypocalcemia
- •Renal impairment (creatinine >1.5x ULN)
结局指标
主要结局
bone density
次要结局
- bone turnover markers