Study Evaluating Denosumab on Vascular and Bone Metabolism in Osteoporotic Chronic Kidney Disease (HDENOBS)
NCT ID: NCT05234047
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
21 participants
OBSERVATIONAL
2022-05-31
2025-02-28
Brief Summary
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* 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
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Detailed Description
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* 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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CKD-5D patients receiving denosumab
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Osteoporosis
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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RECHMPL21_0451
Identifier Type: -
Identifier Source: org_study_id
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