| Trial ID: | L1300 |
| Source ID: | NCT05692297
|
| Associated Drug: |
Denosumab
|
| Title: |
Denosumab Treatment in CKD Patients at High Risk of Fracture
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|Fracture|Bone Density, Low|End Stage Renal Disease
|
| Interventions: |
DRUG: Denosumab|DRUG: Non-denosumab
|
| Outcome Measures: |
Primary: Rate of bone mineral density (BMD) decline at the lumbar spine, Rate of BMD decline =\[(BMD24-BMD Baseline)÷BMD baseline\]\*100%, 24 months | Secondary: Rate of fresh fractures, cardiovascular cerebrovascular adverse events and all-cause mortality, Fresh fractures were new non-traumatic fractures during follow-up. Cardiovascular cerebrovascular adverse events were Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up. All-cause mortality was death from any cause during follow-up., 24 months
|
| Sponsor/Collaborators: |
Sponsor: Capital Medical University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
102
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2023-01-01
|
| Completion Date: |
2025-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-01-25
|
| Locations: |
Nephrology Department of Beijing Jishuitan Hospital, Beijing, Beijing, 100035, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05692297
|
