NCT05234047

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

Observational Study Evaluating the Effect of a Biotherapy Treatment (Anti- RANKL Ligand Antibody: Denosumab) on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 21 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of this study is to evaluate in a population of osteoporotic chronic kidney disease patients the effect of denosumab: * on coronary artery calcification scores evolution after 24 months of followup * on abdominal aorta calcification scores evolution after 24 months of followup * 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 parameters of bone remodelling 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 osteoporotic chronic kidney disease patients the effect of denosumab: * on coronary calcification scores evolution (by multidetector computed tomography) after 24 months of follow-up * on abdominal aorta calcification scores evolution (by plain abdominal Xray) after 24 months of follow-up * 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 parameters of bone remodelling 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

Conditions

• Osteoporosis
• Chronic Kidney Disease 5D

Interventions

Type	Name	Description
PROCEDURE	MDCT (multidetector computed tomography)	MDCT will be performed at inclusion and after 2 years
PROCEDURE	Dual-energy X-ray absorptiometry	DXA will be performed at inclusion, 1 and 2 years after inclusion

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2022-02-10
• Last updated: 2022-04-14