Female With Osteoporosis and Chronic Kidney Disease Clinical Trial
— HDENOOfficial title:
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
| Verified date | April 2022 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 4 |
| Est. completion date | December 10, 2020 |
| Est. primary completion date | December 10, 2020 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 65 Years to 95 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Clinique Médipole Cabestany | Cabestany | |
| France | CHL Castelnau Le Lez | Castelnau-le-Lez | |
| France | CHU Lyon Sud, Nephrology department | Lyon | |
| France | AP-HM, Nephrology department | Marseille | |
| France | AIDER | Montpellier | |
| France | CHU Montpellier, Nephrology department | Montpellier | |
| France | CHU Nice, Nephrology department | Nice | |
| France | CHU Nimes, Nephrology department | Nimes | |
| France | CH Perpignan, Nephrology department | Perpignan |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) | 24 months after inclusion | ||
| Secondary | Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) | 24 months after inclusion | ||
| Secondary | Relative variation of coronary calcification scores after 24 months of follow-up | 24 months after inclusion | ||
| Secondary | Relative variation of abdominal aorta calcification scores after 24 months of follow-up | 24 months after inclusion | ||
| Secondary | Variation of calcium at 6, 12, 18 and 24 months of follow-up | 6, 12, 18 and 24 months after inclusion | ||
| Secondary | Variation of phosphorus at 6, 12, 18 et 24 months of follow-up | 6, 12, 18 and 24 months after inclusion | ||
| Secondary | Morbi-mortality at 24 months of follow-up | 24 months after inclusion | ||
| Secondary | Adverse events occuring during the entire study | 24 months after inclusion |