New Biomarkers of Bone Mineral Metabolism as Cardiovascular Risk Factors in Chronic Kidney Disease Patients

Study Overview
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Brief Summary
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To evaluate the relationships between bone mineral metabolism markers (osteoprotegerin, fibroblast growth factor 23) at inclusion and the occurence of cardiovascular events during a 7 year follow-up.

Official Title
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New Biomarkers of Bone and Mineral Metabolism as Risk Factors for Morbidity/Mortality in Chronic Kidney Disease Patients Not Requiring Dialysis

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Biological: Plasma osteoprotegerin level
* Biological: Plasma fibroblast growth factor 23 level
* Procedure: Vascular calcification score


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who has signed the written consent form Patient with chronic renal failure defined by glomerular filtration rate (GFR) but without dialysis therapy Exclusion Criteria: Pregnancy Patient with chronic renal failure requiring dialysis therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiovascular risk evaluation<br>Measurement at inclusion of plasma osteoprotegerin level, plasma fibroblast growth factor 23 level, vascular calcification score and record of cardiovascular events during the 3 year follow-up | Biological: Plasma osteoprotegerin level<br>* dosage of plasma osteoprotegerin<br>Biological: Plasma fibroblast growth factor 23 level<br>* dosage of plasma fibroblast growth factor 23<br>Procedure: Vascular calcification score<br>* measurement of vascular calcification score by multidetection computerized tomography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of at least one cardiovascular event during the 7 year follow-up according to osteoprotegerin level at inclusion | osteoprotegerin will be measured in picomol/L | 7 years after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of at least one cardiovascular event during the 7 year follow-up according to fibroblast growth factor 23 level at inclusion | fibroblast growth factor 23 will be measured in RU/milliliter | 7 years after inclusion | 
| Occurence of at least one cardiovascular event during the 7 year follow-up according to vascular calcification score at inclusion |  | 7 years after inclusion | 
| Mortality |  | 7 years after inclusion | 
| Kidney functions | values of creatinine | during the 7 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, vascular calcifications, cardiovascular risk