Bone Density and Vascular Calcifications Evolution After Renal Transplant

NCT04713774 | Recruiting

• 1 other identifier: Liege REBON Vasc
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Kidney Transplant; Complications; Bone Loss

Outcome Measures

Primary Outcomes (4)

• Bone density evolution

  Evolution of bone density after kidney transplantation

  At 1 year

• Bone density evolution

  Evolution of bone density after kidney transplantation

  At 2 year

• Bone micro-architecture evolution

  Bone micro-architecture evolution evaluate by HRpQCT after kidney transplantation

  At 1 year

• Bone micro-architecture evolution

  Bone micro-architecture evolution evaluate by HRpQCT after kidney transplantation

  At 2 year

Secondary Outcomes (2)

• Vascular calcification evolution

  At 1 year

• Vascular calcification evolution

  At 3 months, 1 year and 2 years

Interventions

High-resolution peripheral quantitative CT scanner (HRpQCT) DEVICE

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, %).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney recipients aged over 18 and of all sexes recruited from the Centre Hospitalier Universitaire de Liege

You may qualify if:

• At least 18 years old
• Recent kidney transplant patients (\<3 months)
• Medical history available
• Biological parameters of the past year available

You may not qualify if:

• Treatment with bisphosphonate, RANKL inhibitor or SERM with bone action in the last 3 months before the transplant
• Multiple organ transplant patients

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

Centre Hospitalier Universitaire de Liège

Liège, 4300, Belgium

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Antoine Bouquegneau

  University of Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine Bouquegneau

CONTACT

+32473353321; antoine.bouquegneau@gmail.com

Pierre Delanaye

CONTACT

pierre_delanaye@yahoo.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 19, 2021
• Study Start: September 1, 2020
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 13, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)