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RANKL Antibody for Acute Charcot Neuro-osteoarthropathy

NCT05797259 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Charcot Joint of Foot

Interventions

DRUG

Danosumab

60 mg subcutaneous Danosumab

OTHER

Normal Saline

Placebo comparator arm

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-10
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05797259 on ClinicalTrials.gov