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

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

Timeline

Start

2018-11-19

Primary completion

2020-12-10

Completion

2020-12-10

Publications

• Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.

Drugs

Indications