Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
- Conditions
- Female With Osteoporosis and Chronic Kidney Disease
- Interventions
- Drug: NaCl (placebo)
- Registration Number
- NCT02792413
- Lead Sponsor
- University Hospital, Montpellier
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo NaCl (placebo) NaCl 0.9% (1 mL), subcutaneous injection every 6 months for 24 months Denosumab Denosumab Denosumab 60 mg, subcutaneous injection every 6 months for 24 months
- Primary Outcome Measures
Name Time Method Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry) 24 months after inclusion
- Secondary Outcome Measures
Name Time Method Morbi-mortality at 24 months of follow-up 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 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 Relative variation of coronary calcification scores after 24 months of follow-up 24 months after inclusion Adverse events occuring during the entire study 24 months after inclusion
Trial Locations
- Locations (9)
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, France
Clinique Médipole Cabestany🇫🇷Cabestany, France