Study Evaluating Denosumab on Vascular and Bone Metabolism in Osteoporotic Chronic Kidney Disease (HDENOBS)

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: on coronary artery calcification scores evolution after 24 months of followup on abdominal aorta calcification scores evolution after 24 months of followup on bone mineral density (femoral T-score) at 24 months on bone mineral density evolution (femoral T-score) after 24 months of follow-up on bone mineral density evolution (lumbar T-score) after 24 months of follow-up on parameters of bone remodelling after 24 months of follow-up on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up the tolerance after 24 months of follow-up

Detailed Description
-----------------
Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up on bone mineral density (femoral T-score) (by bone densitometry) at 24 months on bone mineral density evolution (femoral T-score) (by bone densitometry) after 24 months of follow-up on bone mineral density evolution (lumbar T-score) (by bone densitometry) after 24 months of follow-up on parameters of bone remodelling after 24 months of follow-up on cardiovascular morbidity (cardiovascular events) and mortality after 24 months of follow-up the tolerance after 24 months of follow-up

Official Title
-----------------
Observational Study Evaluating the Effect of a Biotherapy Treatment (Anti- RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease Patients

Conditions
-----------------
Osteoporosis, Chronic Kidney Disease 5D

Intervention / Treatment
-----------------
* Procedure: MDCT (multidetector computed tomography)
* Procedure: Dual-energy X-ray absorptiometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months Osteoporosis Exclusion Criteria: Pregnancy or breastfeeeding female Current corticoid treatment PTH and Calcium outside the KDIGO guidelines Adynamic bone disease suspicion Cancer or myeloma Serious hepatic cytolysis Serious dental troubles Positive HIV serology Hypersensibility to active substance or one of excipients of denosumab

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CKD-5D patients receiving denosumab<br> | Procedure: MDCT (multidetector computed tomography)<br>* MDCT will be performed at inclusion and after 2 years<br>Procedure: Dual-energy X-ray absorptiometry<br>* DXA will be performed at inclusion, 1 and 2 years after inclusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative variation of coronary calcification scores after 24 months of follow-up |  | 24 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative variation of abdominal aorta calcification scores after 24 months of follow-up |  | 24 months after inclusion | 
| Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) |  | 24 months after inclusion | 
| Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) |  | 24 months after inclusion | 
| Relative variation of radius bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) |  | 24 months after inclusion | 
| Relative variation of whole body bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) |  | 24 months after inclusion | 
| Variation of calcium at 6, 12, 18 and 24 months of follow-up |  | 6, 12, 18 and 24 months after inclusion] | 
| Variation of phosphorus at 6, 12, 18 et 24 months of follow-up |  | 6, 12, 18 and 24 months after inclusion | 
| Variation of bone remodeling at 6, 12, 18 et 24 months of follow-up |  | 6, 12, 18 and 24 months after inclusion | 
| Variation of inflammation at 6, 12, 18 et 24 months of follow-up |  | 6, 12, 18 and 24 months after inclusion | 
| Morbi-mortality at 24 months of follow-up |  | 24 months after inclusion] | 
| Adverse events occuring during the entire study |  | 24 months after inclusion] |