NCT03174366

Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy

Completed Phase 3 Results posted Last updated 23 October 2019

What this trial tests

Phase 3 trial testing Denosumab in Charcot Joint of Foot in 7 participants. Completed in 6 March 2019.

Timeline

16 May 2017

Primary endpoint
18 June 2018

6 March 2019

Quick facts

Lead sponsor	Western University of Health Sciences
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	16 May 2017
Primary completion	18 June 2018
Estimated completion	6 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Denosumab (DENOSUMAB) — full drug profile →

Conditions studied

• Charcot Joint of Foot — all drugs for Charcot Joint of Foot →

Sponsor

Western University of Health Sciences

Who can join

30 and older, male only, with Charcot Joint of Foot. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] Primary · 1 year

Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

Group	Value	95% CI
Intervention Group, Receiving Medication	0
Intervention Group, Receiving Medication	7

Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months. Secondary · 6 months

Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.

Group	Value	95% CI
Intervention Group, Receiving Medication	3.06	± 0.78

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Group, Receiving Medication

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (2 terms — click to expand)

Reaction	System	Intervention Group, Receiv…
Muscle pain, upper extremity	Musculoskeletal and connective tissue disorders	—
Cellulitis	Infections and infestations	—

Data from ClinicalTrials.gov NCT03174366 adverse events section.

Sponsor's own description

Charcot neuroarthropathy (CN) is a debilitating disease primarily affecting poorly controlled diabetic patients with peripheral neuropathy. The consequences of CN include ulcerations of the foot and ankle, osteomyelitis, and severe musculoskeletal deformity. These consequences frequently lead to below-knee amputation of the affected limb.

Currently treatment options are limited, and no pharmaceutical treatment has been efficacious in the medical literature. The purpose of this pilot study is to investigate the potential of the medication denosumab for acute stage Charcot neuroarthropathy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.