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

Not yet recruiting

• Conditions: Chronic Kidney Disease 5D; Osteoporosis
• Interventions: Procedure: MDCT (multidetector computed tomography); Procedure: Dual-energy X-ray absorptiometry

• Registration Number: NCT05234047
• Lead Sponsor: University Hospital, Montpellier

Brief 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

Study Timeline

• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-14
• Study Start: 2022-05
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CKD-5D patients receiving denosumab	Dual-energy X-ray absorptiometry	-
CKD-5D patients receiving denosumab	MDCT (multidetector computed tomography)	-

Primary Outcome Measures

Name	Time	Method
Relative variation of coronary calcification scores after 24 months of follow-up	24 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Relative variation of abdominal aorta calcification scores after 24 months of follow-up	24 months after inclusion
Variation of phosphorus at 6, 12, 18 et 24 months of follow-up	6, 12, 18 and 24 months after inclusion
Relative variation of femoral bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)	24 months after inclusion
Relative variation of whole body bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)	24 months after inclusion
Variation of calcium at 6, 12, 18 and 24 months of follow-up	6, 12, 18 and 24 months after inclusion]
Variation of inflammation at 6, 12, 18 et 24 months of follow-up	6, 12, 18 and 24 months after inclusion
Relative variation of radius bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)	24 months after inclusion
Morbi-mortality at 24 months of follow-up	24 months after inclusion]
Relative variation of lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)	24 months after inclusion
Variation of bone remodeling at 6, 12, 18 et 24 months of follow-up	6, 12, 18 and 24 months after inclusion
Adverse events occuring during the entire study	24 months after inclusion]