RANKL Antibody (Danosumab) for Acute Charcot Neuro-osteoarthropathy Remission in Chronic Kidney Disease

DANCN 01

This study's goal was to determine how denosumab 60 mg, combined with total contact casting and restricted weightbearing status, would affect the treatment of acute CN with CKD. METHODS Participants in the research were those who visited the outpatient foot clinic at PGIMER, CHD in India. During the study period, 446 persons with CN were identified, 102 of whom met the criteria for the first screening, and 78 of whom were ultimately enrolled in the study. Aim: To assess the clinico-radiological remission of Acute Charcot-neuroarthropathy in patients of CKD.

2019-03-10

2023-03-31

2023-03-31

Completed

Early phase I

78

Inclusion Criteria: * Diabetes * Active Charcot neuroarthropathy of either left or right foot * Chronic Kidney disease defined as eGFR\<60 ml/min/m2 and/or Urine protein \>300 mg/day * Presence of all Exclusion Criteria: * Active Pedal ulcer * Active malignancy * Hypocalcemia * Primary Hyperparathyroidism * Pregnancy and Breast Feeding * Prior treatment with anti-RANKL antibody * On corticosteroids

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 78, 'type': 'ACTUAL'}}

2023-08-30