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临床试验/NCT02616627
NCT02616627招募中不适用

Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Bone mineral density by DXA,

研究概览

简要总结

Aims:

  1. To determine whether BMD and muscle mass were associated with fractures and other adverse events in dialysis patients.
  2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.

Method:

In this study, the investigators plan to use DXA to screen for BMD, relevant novel bone microstructure parameters, and body composition in chronic dialysis patients. Also, the investigators plan to use blood testing to measure the blood level of FGF23, calcium, phosphate, PTH and vitamin D. The investigators conduct a prospectively follow up program for these participants to evaluate clinical courses and outcomes. Patients will receive DXA (including BMD and body composition) tests and blood work at baseline and one-year. Muscle power and physical performance will be measured at baseline, 6 months and one-year.

详细描述

Background:

Several large-scale studies enrolling CKD patients discovered that low BMD is still an important risk factor for developing fragility fractures, while chronic dialysis patients are reported to have 4 to5 fold higher risk of fracture compared to general population. However, the relationship between bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and fracture and other adverse events in patients with CKD patients is still unclear. In addition, declining of renal function could affect the normal physiological regulating of blood levels of calcium, phosphate, fibroblast growth factor 23 (FGF23), parathyroid hormone (PTH), and vitamin D, which could influence the bone mineral density of chronic dialysis patients. Recently, it is well known that serum FGF23 is already elevated at the early stage of CKD patients and independently related to CKD. However, there are a limited number of reports indicate that the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in CKD patients.

Aims:

  1. To determine whether BMD by DXA was associated with fractures and other adverse events in dialysis patients.
  2. To explore the effects of the interactions among FGF23, calcium, phosphate, PTH and vitamin D on low bone mineral density and sacropenia in dialysis patients.

Method:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >20 years and one of the below
  • Chronic hemodialysis
  • Chronic peritoneal dialysis

排除标准

  • get pregnant or planning a pregnancy

结局指标

主要结局

Bone mineral density by DXA,

时间窗: one year

Change of BMD between baseline and one year was measured

次要结局

  • Blood tests(one year)
  • Sarcopenia(baseline, 6 month and one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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