| Trial ID: | L1557 |
| Source ID: | NCT05797259
|
| Associated Drug: |
Danosumab
|
| Title: |
RANKL Antibody for Acute Charcot Neuro-osteoarthropathy
|
| Acronym: |
DANCN-CKD
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Charcot Joint of Foot
|
| Interventions: |
DRUG: Danosumab|OTHER: Normal Saline
|
| Outcome Measures: |
Primary: Remission of acute charcot, Proportion of patients achieving remission, 48 week | Secondary: Remission duration, Remission duration in weeks or months, 48 week|Recurrence of CN, Recurrence of active CN defined by temperature \>2 C in the affected foot after documenting remission, 48 week|Mortality, All cause death, Death due to any cause during the study duration
|
| Sponsor/Collaborators: |
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
78
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-03-10
|
| Completion Date: |
2023-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-08-30
|
| Locations: |
Deptt of Endocrinology, Chandigarh, 160012, India
|
| URL: |
https://clinicaltrials.gov/show/NCT05797259
|
