Female With Osteoporosis and Chronic Kidney Disease Clinical Trial
Official 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
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 ;