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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoporosis; Chronic Kidney Disease 5D
• Intervention / Treatment: Procedure: MDCT (multidetector computed tomography); Procedure: Dual-energy X-ray absorptiometry

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 Type: Observational
• Enrollment (Anticipated): 21

Contacts and Locations

• Study Contact: Name: Marion MORENA CARRERE, PhD; Phone Number: +33 411 759893; Email: m-morenacarrere@chu-montpellier.fr
• Study Contact Backup: Name: Jean-Paul CRISTOL, MD, PhD; Phone Number: +33 467 338315; Email: jp-cristol@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

CKD-5D patients with osteoporosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CKD-5D patients receiving denosumab	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative variation of coronary calcification scores after 24 months of follow-up	24 months after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
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 lumbar bone mineral density after 24 months of follow-up (T-score evaluated by osteodensitometry)	24 months after inclusion
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 radius 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 bone remodeling at 6, 12, 18 et 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
Morbi-mortality at 24 months of follow-up	24 months after inclusion]
Adverse events occuring during the entire study	24 months after inclusion]

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Kidney Diseases; Renal Insufficiency, Chronic; Osteoporosis
• Other Study ID Numbers: RECHMPL21_0451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No