NCT05797259

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2019

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

4.1 years

First QC Date

March 6, 2023

Last Update Submit

August 28, 2023

Conditions

Charcot Joint of Foot

Outcome Measures

Primary Outcomes (1)

  • Remission of acute charcot

    Proportion of patients achieving remission

    48 week

Secondary Outcomes (3)

  • Remission duration

    48 week

  • Recurrence of CN

    48 week

  • Mortality

    Death due to any cause during the study duration

Study Arms (2)

Danosumab

EXPERIMENTAL

Danosumab 60mg subcutaneous once at diagnosis

Drug: Danosumab

Placebo

PLACEBO COMPARATOR

Similar Volume, and consistency placebo (Normal Saline) subcutaneous once at diagnosis

Other: Normal Saline

Interventions

DanosumabDRUG

60 mg subcutaneous Danosumab

Also known as: Drug Arm
Danosumab
Normal SalineOTHER

Placebo comparator arm

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Active Pedal ulcer
  • Active malignancy
  • Hypocalcemia
  • Primary Hyperparathyroidism
  • Pregnancy and Breast Feeding
  • Prior treatment with anti-RANKL antibody
  • On corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deptt of Endocrinology

Chandigarh, 160012, India

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2023

First Posted

April 4, 2023

Study Start

March 10, 2019

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)