Regulation of Bone Formation in Renal Osteodystrophy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 主要终点
- Bone Formation Rate
研究概览
简要总结
To examine the effects of two types of active vitamin D (calcitriol and doxercalciferol) and two phosphate binders (sevelamer and calcium carbonate) on the bone disease and blood tests of children with kidney failure
详细描述
Pediatric patients treated with CCPD who displayed biochemical and bone biopsy proven secondary hyperparathyroidism were randomly assigned to one of 2 vitamin D analogues (calcitriol or doxercalciferol) and one of two phosphate binders (sevelamer or calcium carbonate) in a two by two factorial designed prospective trial. Serum biochemical measurements were obtained at baseline and monthly throughout the 8 months of the trial. Bone biopsy was obtaine at baseline and repeated at study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable end-stage kidney disease treated with continuous cycling peritoneal dialysis,
- •Biochemical evidence of secondary hyperparathyroidism (PTH>400 pg/ml) with bone biopsy evidence of high turnover bone disease
排除标准
- •History of parathyroidectomy
- •Growth hormone
- •Prednisone, or other immunosuppressant medication within the past year.
- •Recent history of medication non-compliance.
研究组 & 干预措施
1
Doxercalciferol + Calcium Carbonate
干预措施: 1 alpha D2 (Drug)
1
Doxercalciferol + Calcium Carbonate
干预措施: Calcium Carbonate (Drug)
2
Doxercalciferol + Sevelamer
干预措施: 1 alpha D2 (Drug)
2
Doxercalciferol + Sevelamer
干预措施: Sevelamer HCl (Drug)
3
Calcitriol + Calcium Carbonate
干预措施: 1,25 dihydroxy vitamin D3 (Drug)
3
Calcitriol + Calcium Carbonate
干预措施: Calcium Carbonate (Drug)
4
Calcitriol + Sevelamer
干预措施: 1,25 dihydroxy vitamin D3 (Drug)
4
Calcitriol + Sevelamer
干预措施: Sevelamer HCl (Drug)
结局指标
主要结局
Bone Formation Rate
时间窗: 8 months
次要结局
- Bone histomorphometric parameters other than bone formation rate, biochemical parameters (phosphorus, calcium, PTH, alkaline phosphatase, FGF-23, vitamin D dose)(8 months)