Bone Microarchitecture in the Transplant Patient

NCT02729142 | Completed

• 2 other identifiers: 69HCL14_02232015-A00510-49
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 3

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.

Conditions

Organ Transplant

Keywords

HRpQCT; transplant; bone microarchitecture

Outcome Measures

Primary Outcomes (1)

• Tibial cortical density measured by HR-pQCT

  at 6 months

Secondary Outcomes (25)

• trabecular bone area measured by HR-pQCT

  at 6 months

• total bone area measured by HR-pQCT

  at 6 months

• trabecular number measured by HR-pQCT

  at 6 months

• trabecular thickness measured by HR-pQCT

  at 6 months

• trabecular separation measured by HR-pQCT

  at 6 months

Study Arms (1)

Tibial cortical density evaluation

EXPERIMENTAL

Procedure: Tibial cortical density evaluation

Interventions

Tibial cortical density evaluation PROCEDURE

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.

Tibial cortical density evaluation

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• No health cover
• Ongoing pregnancy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital Femme Mère Enfant

Bron, France

Location

Hopital Edouard Herriot

Lyon, France

Location

CHU Saint Etienne

Saint-Etienne, France

Location

Related Publications (1)

• De Mul A, Leclerc AS, Ginhoux T, Levi C, Confavreux C, Aurelle M, Portefaix A, Bacchetta J. Changes in bone density and microarchitecture in adolescents undergoing a first kidney transplantation: a prospective study. Eur J Pediatr. 2024 Dec;183(12):5303-5312. doi: 10.1007/s00431-024-05777-z. Epub 2024 Oct 9.

  PMID: 39384649 RESULT

Study Officials

• Charlene LEVI, Doctor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2016
• First Posted: April 6, 2016
• Study Start: June 7, 2016
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2020
• Last Updated: August 22, 2025

Record last verified: 2020-11

Locations

FR (3)