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Recruiting Observational

Bone Density and Vascular Calcifications Evolution After Renal Transplant

NCT04713774 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2020-09-01
Last updated
2024-12-18

Condition(s) studied

Kidney Transplant; ComplicationsBone Loss

Investigational drug(s) / intervention(s)

High-resolution peripheral quantitative CT scanner (HRpQCT)

High-resolution peripheral quantitative CT scanner (HRpQCT): HR-pQCT images of the distal radius and distal tibia (non-dominant, non-fractured limb) will be obtained using the XtremeCT device with standard protocols. HR-pQCT images wil be analysed with standard software and extended cortical measures software. This software identifies the periosteal and endosteal boundaries, enabling assessment of cortical micro- structural bone properties, including apparent cortical thickness (Ct.Th, mm), cortical tissue mineral density (TMD, mgHA/cm3) and cortical porosity (Ct.Po, %).

Study summary

The investigators project is based on:

* Assessment of bone architecture by high resolution peripheral scanner (HRpQCT) and bone densitometry (DEXA);
* The non-invasive detection of vascular calcifications (by abdominal CT scanner) and bone abnormalities associated with kidney transplantation, as well as the analysis of evolution over time;
* Longitudinal evaluation of nephrological clinical parameters (glomerular filtration rate, number and type of rejections, immunosuppressive medications) as well as biological and urinary parameters of mineral metabolism (parathormone, sclerostin, bone alkaline phosphatase) depending on the type and severity of bone abnormalities;
* The evaluation of these nephrological clinical parameters and of the biological parameters of mineral metabolism depending on the extent and evolution of vascular calcifications but also on bone morphology;
* The study of possible relationships between bone mass and muscle mass (and functioning)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * At least 18 years old * Recent kidney transplant patients (\<3 months) * Medical history available * Biological parameters of the past year available Exclusion Criteria: * Treatment with bisphosphonate, RANKL inhibitor or SERM with bone action in the last 3 months before the transplant * Multiple organ transplant patients

Primary outcome measure(s)

  • Bone density evolution — At 1 year
    Evolution of bone density after kidney transplantation
  • Bone density evolution — At 2 year
    Evolution of bone density after kidney transplantation
  • Bone micro-architecture evolution — At 1 year
    Bone micro-architecture evolution evaluate by HRpQCT after kidney transplantation
  • Bone micro-architecture evolution — At 2 year
    Bone micro-architecture evolution evaluate by HRpQCT after kidney transplantation

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Universitaire de Liège Liège Belgium Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04713774 on ClinicalTrials.gov ↗ ← All trials in Belgium