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

RECHMPL15_0496

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

2018-11-19

2020-12-10

2020-12-10

Terminated

Early phase I

4

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 4, 'type': 'ACTUAL'}}

2023-08-09