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

University Hospital Center (CHU)

Status: Not yet enrolling

Conditions: Osteoporosis; Chronic Kidney Disease 5D

Treatments: Procedure: Dual-energy X-ray absorptiometry; Procedure: MDCT (multidetector computed tomography)

Study type: Observational

Funder types: Other

Identifiers

NCT05234047

RECHMPL21_0451

Details and patient eligibility

About

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

Full 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

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic kidney disease stage 5D patient, hemodialyzed with extracorporeal treatment for at least 3 months
• Osteoporosis

Exclusion criteria

• Pregnancy or breastfeeeding female
• Current corticoid treatment
• PTH and Calcium outside the KDIGO guidelines
• Adynamic bone disease suspicion
• Cancer or myeloma
• Serious hepatic cytolysis
• Serious dental troubles
• Positive HIV serology
• Hypersensibility to active substance or one of excipients of denosumab

Trial design

21 participants in 1 patient group

CKD-5D patients receiving denosumab

Treatment:

Procedure: MDCT (multidetector computed tomography)

Procedure: Dual-energy X-ray absorptiometry