Osteoporosis, Chronic Kidney Disease 5D
Conditions
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
Interventions
PROCEDUREMDCT (multidetector computed tomography)
MDCT will be performed at inclusion and after 2 years
PROCEDUREDual-energy X-ray absorptiometry
DXA will be performed at inclusion, 1 and 2 years after inclusion
Sponsors
University Hospital, Montpellier
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative variation of coronary calcification scores after 24 months of follow-up | 24 months after inclusion |
Secondary
| Measure | Time frame |
|---|---|
| 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] |
| Relative variation of abdominal aorta calcification scores after 24 months of follow-up | 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] |
| Variation of phosphorus at 6, 12, 18 et 24 months of follow-up | 6, 12, 18 and 24 months after inclusion |
Contacts
Primary ContactJean-Paul CRISTOL, MD, PhD
Backup ContactMarion MORENA CARRERE, PhD
Outcome results
None listed