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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Denosumab

Criteria

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)