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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
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.
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.
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
Nîmes, France
CH Perpignan, Nephrology department
Perpignan, France
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)
Time frame: 24 months after inclusion
Relative variation of coronary calcification scores after 24 months of follow-up
Time frame: 24 months after inclusion
Relative variation of abdominal aorta calcification scores after 24 months of follow-up
Time frame: 24 months after inclusion
Variation of calcium at 6, 12, 18 and 24 months of follow-up
Time frame: 6, 12, 18 and 24 months after inclusion
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up
Time frame: 6, 12, 18 and 24 months after inclusion
Morbi-mortality at 24 months of follow-up
Time frame: 24 months after inclusion
Adverse events occuring during the entire study
Time frame: 24 months after inclusion
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