A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
研究概览
简要总结
The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.
详细描述
Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age older than 18
- •Self-describes as White race
排除标准
- •Lower extremity amputations
- •Non-ambulatory
- •Paget´s disease of bone
- •Current hyperthyroidism, untreated hypothyroidism
- •Medical diseases (end stage liver, intestinal malabsorption)
- •Use within the prior year pod anti-seizure medications that induce the cytochrome P450 system, testosterone, estrogen, selective estrogen receptor modulators
- •Weight >300 pounds
- •Dual organ transplant
- •Myocardial infarction or stroke
- •Tobacco use within the past year
研究组 & 干预措施
Vitamin D3 plus Calcitriol
1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months
1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months
干预措施: Vitamin D3 (Drug)
Vitamin D3 plus Calcitriol
1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months
1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months
干预措施: Calcitriol (Drug)
Vitamin D3 plus Placebo
1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months
1 pill of placebo (sugar pill) per day for 12 months
干预措施: Vitamin D3 (Drug)
Vitamin D3 plus Placebo
1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months
1 pill of placebo (sugar pill) per day for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
时间窗: Baseline, 12 months
Novel high resolution bone imaging can separately measure and quantify cortical and trabecular responses to bone active treatments. Finite element analysis (FEA) can be applied to HRpQCT datasets. to provide a computational estimate of bone mechanical competence that has been validated against true compressive tests of bone stiffness and strength.
次要结局
- Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation(Baseline, 12 months)
- Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods(Baseline, 12 months)
- Percent Change of Cortical Porosity Pre- and Post-intervention(Baseline, 12 months)
- Percent Change in Vascular Calcifications Loads of the Lower Extremity(Baseline, 12 months)
- Number of Patients With Vascular Calcifications of the Lower Extremity(Baseline, 12 months)
- Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels(Baseline, 12 months)
- Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment(Baseline, 12 months)