Clinical trial NCT05234047: Study Evaluating Denosumab on Vascular and Bone Metabolism in Osteoporotic Chronic Kidney Disease (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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Chronic Kidney Disease 5D
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD-5D patients with osteoporosis

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

Eligibility criteria: 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

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