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