Bone Microarchitecture in the Transplant Patient

Organ Transplant Clinical Trial

— TRANSOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729142
• Other study ID #: 69HCL14_0223
• Secondary ID: 2015-A00510-49
• Status: Completed
• Phase: N/A
• Start date: June 7, 2016
• Est. completion date: October 8, 2020

Study information

• Verified date: November 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Organ Transplant

Intervention

Procedure:
• Tibial cortical density evaluation
Bone evaluation in transplant patients will be performed by HR-pQCT at baseline (either within 6 months before surgery or within 15 days following surgery) and 6 months post-intervention in order to assess its evolution.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron
France	Hopital Edouard Herriot	Lyon
France	CHU Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tibial cortical density measured by HR-pQCT		at 6 months
Secondary	trabecular bone area measured by HR-pQCT		at 6 months
Secondary	total bone area measured by HR-pQCT		at 6 months
Secondary	trabecular number measured by HR-pQCT		at 6 months
Secondary	trabecular thickness measured by HR-pQCT		at 6 months
Secondary	trabecular separation measured by HR-pQCT		at 6 months
Secondary	cortical perimeter measured by HR-pQCT		at 6 months
Secondary	Evaluation of bone markers by measuring calcium		at 6 months
Secondary	Evaluation of bone markers by measuring phosphate		at 6 months
Secondary	Evaluation of bone markers by measuring alkaline reserve		at 6 months
Secondary	Evaluation of bone markers by measuring PTH		at 6 months
Secondary	Evaluation of bone markers by measuring 25OHD3		at 6 months
Secondary	Evaluation of bone markers by measuring 1-25 OHD3		at 6 months
Secondary	Evaluation of bone markers by measuring FGF23		at 6 months
Secondary	Evaluation of bone markers by measuring CTX		at 6 months
Secondary	Evaluation of bone markers by measuring total alkaline phosphatase		at 6 months
Secondary	Evaluation of bone markers by measuring bone alkaline phosphatase		at 6 months
Secondary	Evaluation of bone markers by measuring osteocalcin		at 6 months
Secondary	Bone mineral density assessed by DXA		at 6 months
Secondary	Fractures onset assessed by DXA		at 6 months
Secondary	Cardiovascular events (death from cardiovascular cause, heart attack, stroke)		at 6 months
Secondary	PTH	For kidney transplant only	Baseline
Secondary	1-25 OHD	For kidney transplant only	Baseline
Secondary	FGF 23	For kidney transplant only	Baseline
Secondary	calcium	For kidney transplant only	Baseline
Secondary	phosphate	For kidney transplant only	Baseline