Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02523209
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2015-07-15
Brief Title:
Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease CKD Candidates for Renal Transplantation
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease CKD Candidates for Renal Transplantation - A Monocentric Study
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSBONE
Brief Summary:
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 its 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None