Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation (TRANSBONE)
May 29, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne
Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation - A Monocentric Study
While the duration of renal transplant function has increased over the last decade kidney transplanted patients (KTP) still exhibit a fracture risk 4 times higher than in the general population.
Fracture risk remains increased despite the improvement of immunosuppressive therapies (IST) that allowed the reduction of steroid administration.
Potential explanations for this could be 1) that Chronic Kidney Disease (CKD) induces renal osteodystrophy that occurs before kidney transplanted, impairs bone metabolism and promotes bone fragility ; 2) that kidney transplanted patients are older and older (14% of kidney transplanted patients were older than 70 in 2011 in France), ageing being a major risk factor for fractures 3) IST, besides steroid, may have deleterious effects on bone and 4) that secondary hyperparathyroidism, a risk factor of fractures, persists after kidney transplanted .
Thus, the pathophysiology and epidemiology of bone fragility of kidney transplanted patient remains insufficiently characterized.
Despite these data, and contrarily to what is done for patients candidates for cardiac transplantation, there is no general consensus for performing bone evaluation before kidney transplanted .
Thus it's necessary to individualize the management of bone fragility and prevent fractures according to strategies that remain to be defined, provided that patients at risk are better detected.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Bone fragility is determined by quantitative parameters (bone mass) and qualitative parameters including macro- and micro-architecture (especially cortical porosity and thickness).
The Dual Energy X-ray Absorptiometry (DEXA ) measurement of Bone Mineral Density (BMD) is a robust predictor of fracture risk in the non-uremic population.
Micro and macro-architecture can be measured with High Resolution peripheral micro Computerized Tomography (HRpQCT) at the ankle and the wrist .
Some recent studies suggested that HRpQCT could be a better fracture predictor than DEXA in uremic populations.
In this context, the aim of our project is to describe in a cross sectional study the bone status of CKD patients, candidates for kidney transplanted .
It will be 1) calculated the prevalence of cortical osteoporosis as assessed by cortical thickness at the ankle and the wrist (primary end point), 2) analyzed other HRpQCT microarchitecture quantitative parameters and 3) defined the biological and clinical factors associated with bone degradation (secondary endpoints).
This population will be compared to age and sex matched normal subjects (collaboration with Pr Rizzoli, Geneva, Switzerland).
The DEXA and HRpQCT will be compared for detection of patients at risk for fracture.
Study Type
Observational
Enrollment (Actual)
102
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint-Etienne, France, 42055
- CHU Saint-Etienne
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patient with end stage renal disease
Description
Inclusion Criteria:
- Serum parathyroidal Hormon (PTH ) > 65pg/ml
- Stage 5 or 5D Chronic Kidney Disease patients
- Patient registered (or on the verge of being registered) on the KT waiting list at St-Etienne Hospital, France
- Written consent of patient
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Bone quality and quantity
measure of bone quality and quantity parameters by HRpQCT and by DEXA
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HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at the tibia and the radius levels in humans.
The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA (Dual Energy X-ray Absorptiometry) device that allows short duration measurements ( <15 min).
It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of patients with cortical osteoporosis
Time Frame: Day1
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A Cortical osteoporosis is a composite outcome measured with two devices : HR-pQCT and DEXA parameters measured with HR-pQCT on ankle (tibia) and wrist (radius) are : Cortical thickness (mm).
Parameters measured with DEXA on spine and femoral neck are : Bone Mineral Density (BMD, g/cm2)
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Day1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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clinical and biological factors associated with bone degradation
Time Frame: day 1
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clinical and biological factors are a composite outcome : Clinical parameters measured are : dialysis vintage, age, transplantation history , sex, Immunosuppressive Therapies, steroid dose, parathyroidectomy history, Biological parameters measured are Calcium, Phosphorus, Parathormone, bicarbonates, albumin, Bone alkaline phosphatase. Bone degradation is a composite measure : parameters measured with HR-pQCT on ankle (tibia) and wrist (radius) are : Cortical thickness (mm), Total mineral volumetric density (mg/ccm HA), trabecular mineral volumetric density (mg/ccm HA), Cortical mineral volumetric density (mg/ccm HA), Trabecular Number (1/mm), Trabecular thickness (mm), Trabecular Separation (mm), Mean distance between trabecular (mm) Parameters measured with DEXA on spine and femoral neck are : Bone Mineral Density (BMD, g/cm2), T-Score, Z-Score, Trabecular bone score (TBS). |
day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marie-Hélène LAFAGE-PROUST, PhD, CHU Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2014
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
July 15, 2015
First Submitted That Met QC Criteria
August 12, 2015
First Posted (Estimate)
August 14, 2015
Study Record Updates
Last Update Posted (Actual)
May 31, 2017
Last Update Submitted That Met QC Criteria
May 29, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1408080
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