Female With Osteoporosis and Chronic Kidney Disease
Conditions
Keywords
osteoporosis, chronic kidney disease, anti-RANK ligand antibody, bone mineral density, vascular calcifications
Brief summary
Aim of this study is to evaluate in a population of old osteoporotic chronic kidney disease females the effect of denosumab: * 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 coronary and abdominal aorta calcification scores evolution after 24 months of follow-up * on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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 old osteoporotic chronic kidney disease females the effect of denosumab: * 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 coronary and abdominal aorta calcification scores evolution (by multiple detector computed tomography and plain abdominal X-ray) after 24 months of follow-up * on parameters of bone remodelling (OPG, RANKL, sclerostin, DKK-1), of mineral and calcium metabolism (FGF23 Ct, Klotho, PTH, 25(OH) vitamin D3, phosphorus, calcium, bone alklaline phosphatase, osteocalcin, CTX), of inflammation (CRP) 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
DRUGDenosumab
Patients will receive a subcutaneous injection of Denosumab every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.
DRUGNaCl (placebo)
Patients will receive a subcutaneous injection of NaCl every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Patient of 65 years or older * Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months * Patient with osteoporosis (history of bone fracture or T-scoring \< -2.5 SD) * PTH levels in the serum in agreement with the KDIGO guidelines, in the absence of treatment with Cinacalcet.
Exclusion criteria
* Cinacalcet treatment * Calcium parameters (PTH, 25(OH) vitamin D3, Calcium) outside the KDIGO guidelines * Suspicion of lower bone remodeling * Hypersensibility to active substance or one of excipients of denosumab * Patient with a cancer or myeloma * Patient with severe heaptic cytolysis * Patients with severe teeth problems * Patient positive for HIV * Patient involved in another biomedical research * Vulnerable patients (protected by the law, under guardianship, deprived of freedom)
Design outcomes
Primary
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Relative variation of coronary calcification scores after 24 months of follow-up | 24 months after inclusion |
| Relative variation of abdominal aorta calcification scores after 24 months of follow-up | 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 lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) | 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 |
Countries
France
Outcome results
None listed