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Clinical Trials/NCT02729142
NCT02729142
Completed
Not Applicable

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

Hospices Civils de Lyon3 sites in 1 country137 target enrollmentJune 7, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Organ Transplant
Sponsor
Hospices Civils de Lyon
Enrollment
137
Locations
3
Primary Endpoint
Tibial cortical density measured by HR-pQCT
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 7, 2016
End Date
October 8, 2020
Last Updated
8 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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)

Exclusion Criteria

  • No health cover
  • Ongoing pregnancy

Outcomes

Primary Outcomes

Tibial cortical density measured by HR-pQCT

Time Frame: at 6 months

Secondary Outcomes

  • 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)

Study Sites (3)

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