Analysis of Bone Microarchitecture With HR-pQCT of Patients With Chronic Kidney Disease (CKD) Candidates for Renal Transplantation

NCT02523209 | Completed

• 1 other identifier: 1408080
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Kidney Diseases; Hyperparathyroidism, Secondary

Keywords

Osteoporosis; chronic kidney disease; kidney transplantation; fracture risk

Outcome Measures

Primary Outcomes (1)

• Number of patients with cortical osteoporosis

  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)

  Day1

Secondary Outcomes (1)

• clinical and biological factors associated with bone degradation

  day 1

Study Arms (1)

Bone quality and quantity

measure of bone quality and quantity parameters by HRpQCT and by DEXA

Device: HR-pQCT; Device: DEXA

Interventions

HR-pQCT DEVICE

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.

Bone quality and quantity

DEXA DEVICE

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

Bone quality and quantity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with end stage renal disease

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Osteoporosis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marie-Hélène LAFAGE-PROUST, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: August 14, 2015
• Study Start: September 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

FR (1)