Health TrialsbyHealthPanel

Bone Density and Vascular Calcifications Evolution After Renal Transplant

ConditionsKidney Transplant; ComplicationsBone Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Liege

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old

Recent kidney transplant patients (<3 months)

Medical history available

Biological parameters of the past year available

Disqualifiers

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

Multiple organ transplant patients

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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, %).

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Bone density evolution

Evolution of bone density after kidney transplantation

Time frame
At 1 year
2

Bone density evolution

Evolution of bone density after kidney transplantation

Time frame
At 2 year
3

Bone micro-architecture evolution

Bone micro-architecture evolution evaluate by HRpQCT after kidney transplantation

Time frame
At 1 year
4

Bone micro-architecture evolution

Bone micro-architecture evolution evaluate by HRpQCT after kidney transplantation

Time frame
At 2 year

Secondary outcomes

1

Vascular calcification evolution

Evolution of vascular calcification evaluated by abdominal calcification score on CT-SCan after kidney transplantation

Time frame
At 1 year
2

Vascular calcification evolution

Evolution of vascular calcification evaluated by abdominal calcification score on CT-SCan after kidney transplantation

Time frame
At 3 months, 1 year and 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Liege

Lead sponsor

Source ClinicalTrials.gov
Apply now