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

NCT02792413 PHASE4 TERMINATED

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

Details

Lead sponsor	University Hospital, Montpellier
Phase	PHASE4
Status	TERMINATED
Enrolment	4
Start date	Mon Nov 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Dec 10 2020 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Female With Osteoporosis and Chronic Kidney Disease

Interventions

• Denosumab
• NaCl (placebo)

Countries

France