NCT00859612已完成不适用
Renal Osteodystrophy: A Fresh Approach
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 464
- 试验地点
- 1
- 主要终点
- Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
研究概览
简要总结
There are two major goals of this project:
- Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
- Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Aged 18 years or older;
- •Chronic maintenance dialysis of at least 3 months' duration;
- •Mental competence;
- •Willingness to participate in the study;
- •Calcidiol levels within normal range.
排除标准
- •Pregnancy;
- •Systemic illnesses or organ diseases that may affect bone (except type 1 or type 2 diabetes mellitus);
- •Clinical condition that may limit study participation (e.g., unstable angina, respiratory distress, infections).
- •Chronic alcoholism and/or drug addiction;
- •Participation in a study of an investigational drug during the past 90 days;
- •Allergy to tetracycline.
- •Planning to move out of the area within 2 years of the study;
- •On active transplant list;
- •Treatment within last 6 months with drugs that may affect bone metabolism (except for treatment with calcitriol, vitamin D analogs and/or calcimimetics).
- •Calcidiol level below the normal range. The current routine clinical practice in our dialysis clinics is to check calcidiol status twice yearly and supplement with vitamin D according to serum calcidiol levels. It is therefore unlikely that a substantial number of patients will be excluded due to this exclusion criterion.
结局指标
主要结局
Comparison of DXA and QCT for diagnosis of bone loss in CKD-5 patients and determination of the prevalence of low bone turnover in CKD-5 patients with bone loss.
时间窗: 4 years
Because each method (QCT or DXA) yields a dichotomous response (bone loss: yes or no), the proportion of patients with a bone loss will be compared between the 2 methods by using the McNemar statistic for correlated proportions.
次要结局
- Identification of the optimal combination of noninvasive tests for definition of the turnover component of ROD.(4 years)
研究者
Hartmut Malluche, MD
Professor and Chief
University of Kentucky
研究点 (1)
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