Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
研究概览
简要总结
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.
详细描述
The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defined by a calculated creatine clearance of 35ml/min or more and serum creatinine less than 3.0
排除标准
- •Dual X-ray Absorptiometry (DXA) T-score at the spine or hip of -3 or lower
- •History of more than one vertebral or non-vertebral fracture in the past two years
- •Abnormalities of the esophagus which delay esophageal emptying
- •Inability to stay upright for 30 minutes
- •Pregnant, nursing women or women not using an effective form of birth control
- •Hypocalcemia
- •Hypercalcemia
- •Calculated creatinine clearance of <35 ml/min or serum creatinine > 3.0
- •Patients already treated with bisphosphonates within the past one year
- •Patients unable to undergo DXA
- •Patients with cancer
研究组 & 干预措施
1 Zoledronic Acid
Zoledronic Acid 4mg intravenously once a year for 2 years
干预措施: Zoledronic Acid (Drug)
2 Alendronate
Alendronate 70mg orally once a week for 2 years
干预措施: Alendronate (Drug)
3 Placebo
Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily
干预措施: Calcium with vitamin D (Combination Product)
结局指标
主要结局
Percentage Change in Posterior Anterior (PA) Spine Bone Density From Baseline to 24 Months Post Transplant
时间窗: 24 months
Posterior Anterior (PA) spine bone density was measured by dual energy x-ray absorptiometry (DXA) at baseline and 24 months post transplant. The percentage change in the PA spine bone density was then compared from baseline to 24 months post transplant.
次要结局
- Compliance With Zoledronic Acid, Alendronate and/or Calcium/Vitamin D Supplementation(24 months)