Clinical trial NCT02729142: Bone Microarchitecture in the Transplant Patient
Official title: Longitudinal Monitoring of Bone Microarchitecture by High Resolution Peripheral Quantitative Computed Tomography of (HR-pQCT) in the Transplant Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Transplant
Keywords: HRpQCT
transplant
bone microarchitecture
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 137
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Tibial cortical density measured by HR-pQCT
timeFrame: at 6 months
Secondary outcomes:
measure: trabecular bone area measured by HR-pQCT
timeFrame: at 6 months
measure: total bone area measured by HR-pQCT
timeFrame: at 6 months
measure: trabecular number measured by HR-pQCT
timeFrame: at 6 months
measure: trabecular thickness measured by HR-pQCT
timeFrame: at 6 months
measure: trabecular separation measured by HR-pQCT
timeFrame: at 6 months
measure: cortical perimeter measured by HR-pQCT
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring calcium
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring phosphate
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring alkaline reserve
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring PTH
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring 25OHD3
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring 1-25 OHD3
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring FGF23
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring CTX
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring total alkaline phosphatase
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring bone alkaline phosphatase
timeFrame: at 6 months
measure: Evaluation of bone markers by measuring osteocalcin
timeFrame: at 6 months
measure: Bone mineral density assessed by DXA
timeFrame: at 6 months
measure: Fractures onset assessed by DXA
timeFrame: at 6 months
measure: Cardiovascular events (death from cardiovascular cause, heart attack, stroke)
timeFrame: at 6 months
measure: PTH
timeFrame: Baseline
measure: 1-25 OHD
timeFrame: Baseline
measure: FGF 23
timeFrame: Baseline
measure: calcium
timeFrame: Baseline
measure: phosphate
timeFrame: Baseline
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: Hospices Civils de Lyon
name: Charlene LEVI, Doctor
role: PRINCIPAL_INVESTIGATOR
References: