| Trial ID: | L1110 |
| Source ID: | NCT02792413
|
| Associated Drug: |
Denosumab
|
| Title: |
Study Evaluating Denosumab on Bone and Vascular Metabolism in Osteoporotic Chronic Kidney Disease
|
| Acronym: |
HDENO
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Female With Osteoporosis and Chronic Kidney Disease
|
| Interventions: |
DRUG: Denosumab|DRUG: NaCl (placebo)
|
| Outcome Measures: |
Primary: 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|Relative variation of coronary calcification scores after 24 months of follow-up, 24 months after inclusion|Relative variation of abdominal aorta calcification scores after 24 months of follow-up, 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 phosphorus 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
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Montpellier
|
| Gender: |
FEMALE
|
| Age: |
OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
4
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2018-11-19
|
| Completion Date: |
2020-12-10
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-09
|
| Locations: |
Clinique Médipole Cabestany, Cabestany, France|CHL Castelnau Le Lez, Castelnau-le-Lez, France|CHU Lyon Sud, Nephrology department, Lyon, France|AP-HM, Nephrology department, Marseille, France|AIDER, Montpellier, France|CHU Montpellier, Nephrology department, Montpellier, France|CHU Nice, Nephrology department, Nice, France|CHU Nimes, Nephrology department, Nimes, France|CH Perpignan, Nephrology department, Perpignan, France
|
| URL: |
https://clinicaltrials.gov/show/NCT02792413
|
