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临床试验/NCT02729142
NCT02729142已完成不适用

Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) in the Transplant Patient

Hospices Civils de Lyon3 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2016年6月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
137
试验地点
3
主要终点
Tibial cortical density measured by HR-pQCT

研究概览

简要总结

The optimal management of calcium and phosphate metabolism regulation in chronic kidney disease (CKD) is important in preventing fracture risk and vascular calcification and thus morbidity and mortality, global and vascular.

Kidney transplant in a CKD context, usually with a pre-existing underlying renal osteodystrophy, malnutrition, chronic inflammation, hypogonadism and immunosuppression protocols still often made up of high-dose corticosteroid therapy, are all theoretical factors of post-transplantation bone disease. For other solid organ transplants, even though there is generally no underlying renal osteodystrophy before the transplant, the proportion of osteoporotic patients at the time of transplant is substantial. The bone risk in the immediate post-transplant period is notable.

Patients' follow-up is based on biological, radiological and histological tools. Bone densitometry (DXA) is used to measure bone mass. However, recent international recommendations do not consider DXA as a valid tool to assess bone health in CKD patients. Moreover, it is less informative than peripheral quantitative tomography resolution (HR-pQCT). This latest technique, available in Lyon and Saint-Etienne, is more precise, allowing a three-dimensional study of the trabecular microarchitecture and compartmental volumetric bone density (total, cortical, trabecular), while similar to DXA in terms of radiation (less than 5 μSv). The prevention of cardiovascular risk factors is also part of the daily care of patients with a regular cardiac monitoring (heart ultrasound) and vascular (blood pressure, Doppler of the supra-aortic trunks).

TRANSOS study aims to evaluate in a prospective cohort (longitudinal follow-up of 6 months), the bone status in patients receiving solid organ transplantation in the University Hospitals of Lyon and Saint-Etienne, using DXA and HR-pQCT (at baseline and month 6), in combination with classical biological and cardiovascular monitoring. Transplantation is an important activity in these two hospitals and this protocol provides the same bone follow-up for all solid organ transplants, with a reliable, efficient, non-invasive and low-dose radiation tool.

The primary objective of TRANSOS study is to evaluate changes in tibial cortical density between the baseline and the 6th month post-transplant measured by HR-pQCT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Patient over 10 year-old
  • Patient receiving a first solid organ transplant within involved hospitals (Lyon, Saint Etienne): kidney, heart, kidney-pancreas, lung
  • Informed consent signed by the patients or their parents (minors)

排除标准

  • No health cover
  • Ongoing pregnancy

结局指标

主要结局

Tibial cortical density measured by HR-pQCT

时间窗: at 6 months

次要结局

  • 1-25 OHD(Baseline)
  • Evaluation of bone markers by measuring osteocalcin(at 6 months)
  • trabecular bone area measured by HR-pQCT(at 6 months)
  • Evaluation of bone markers by measuring alkaline reserve(at 6 months)
  • Evaluation of bone markers by measuring calcium(at 6 months)
  • Evaluation of bone markers by measuring 1-25 OHD3(at 6 months)
  • total bone area measured by HR-pQCT(at 6 months)
  • trabecular number measured by HR-pQCT(at 6 months)
  • Evaluation of bone markers by measuring 25OHD3(at 6 months)
  • Evaluation of bone markers by measuring total alkaline phosphatase(at 6 months)
  • Evaluation of bone markers by measuring bone alkaline phosphatase(at 6 months)
  • Bone mineral density assessed by DXA(at 6 months)
  • Cardiovascular events (death from cardiovascular cause, heart attack, stroke)(at 6 months)
  • PTH(Baseline)
  • trabecular separation measured by HR-pQCT(at 6 months)
  • cortical perimeter measured by HR-pQCT(at 6 months)
  • Evaluation of bone markers by measuring phosphate(at 6 months)
  • trabecular thickness measured by HR-pQCT(at 6 months)
  • Evaluation of bone markers by measuring PTH(at 6 months)
  • Fractures onset assessed by DXA(at 6 months)
  • FGF 23(Baseline)
  • calcium(Baseline)
  • Evaluation of bone markers by measuring FGF23(at 6 months)
  • Evaluation of bone markers by measuring CTX(at 6 months)
  • phosphate(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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