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

Osteoporosis Clinical Trial

— HDENOBS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05234047
• Other study ID #: RECHMPL21_0451
• Status: Not yet recruiting
• Start date: May 2022
• Est. completion date: February 2025

Study information

• Verified date: April 2022
• Source: University Hospital, Montpellier
• Contact: Jean-Paul CRISTOL, MD, PhD
• Phone: +33 467 338315
• Email: jp-cristol[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 21
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease 5D
• Kidney Diseases
• Osteoporosis
• Renal Insufficiency, Chronic

Intervention

Procedure:
• MDCT (multidetector computed tomography)
MDCT will be performed at inclusion and after 2 years
• Dual-energy X-ray absorptiometry
DXA will be performed at inclusion, 1 and 2 years after inclusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

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