Bone Microarchitecture in the Transplant Patient

Not Applicable

Completed

• Conditions: Organ Transplant
• Interventions: Procedure: Tibial cortical density evaluation

• Registration Number: NCT02729142
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-25
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Study Start: 2016-06-07
• Primary Completion: 2020-10-08
• Study Completion: 2020-10-08
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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)

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Exclusion Criteria

• No health cover
• Ongoing pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tibial cortical density evaluation	Tibial cortical density evaluation	-

Primary Outcome Measures

Name	Time	Method
Tibial cortical density measured by HR-pQCT	at 6 months

Secondary Outcome Measures

Name	Time	Method
Bone mineral density assessed by DXA	at 6 months
trabecular bone area measured by HR-pQCT	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
Evaluation of bone markers by measuring osteocalcin	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
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
Evaluation of bone markers by measuring alkaline reserve	at 6 months
Cardiovascular events (death from cardiovascular cause, heart attack, stroke)	at 6 months
PTH	Baseline	For kidney transplant only
1-25 OHD	Baseline	For kidney transplant only
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	For kidney transplant only
calcium	Baseline	For kidney transplant only
Evaluation of bone markers by measuring FGF23	at 6 months
Evaluation of bone markers by measuring CTX	at 6 months
phosphate	Baseline	For kidney transplant only

Trial Locations

Locations (3)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

CHU Saint Etienne; 🇫🇷 Saint-Étienne, France