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

NCT03174366 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20159178
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Charcot Joint of Foot

Outcome Measures

Primary Outcomes (1)

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

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

  1 year

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

Intervention Group, receiving medication

EXPERIMENTAL

Subjects in this group will be receiving medication (denosumab)

Drug: Denosumab

Interventions

Denosumab DRUG

Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.

Intervention Group, receiving medication

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women \> 30 years old
• Subject is able and willing to comply with study procedures, and is able to give signed and dated consent
• Subject meets criteria for diagnosis of Diabetes Mellitus Type 1 or 2, active Charcot neuroarthropathy, and peripheral neuropathy
• Subjects with serum calcium or albumin-adjusted serum calcium ≥2.0 mmol/L (8.0mg/dL)

You may not qualify if:

• Unable to provide signed and dated consent.
• Charcot neuroarthropathy of the ipsilateral lower extremity, diagnosed over 1 month prior.
• Prior foot or ankle surgery of the ipsilateral lower extremity.
• Prior amputation at any level of either lower extremity.
• Prior foot or ankle fracture of the ipsilateral lower extremity unrelated to the current acute CN episode.
• Currently has any of the following:
• Infection
• Foot ulceration
• Hypocalcemia
• Creatinine clearance less than 30 mL/min or on dialysis
• Pre-existing disturbance of mineral metabolism (e.g., hypoparathyroidism unstable on therapy, thyroid or parathyroid surgery, vitamin D deficiency, malabsorption syndromes, excision of small intestine, history of diseases affecting bone metabolism) that has not been effectively corrected or treated.
• Have undergone revascularization procedures of the lower extremities.
• Female subjects who are pregnant or planning to breastfeed should not participate in this study.
• Determined to have poor oral hygiene after dental screening or are at increased risk for developing osteonecrosis of the jaw.
• History of osteonecrosis of the jaw.

Sponsors & Collaborators

• Western University of Health Sciences: lead

Study Sites (1)

Western University of Health Sciences

Pomona, California, 91711, United States

Location

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: David Shofler
• Organization: Western University of Health Sciences

dshofler@westernu.edu

9097063898

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: June 2, 2017
• Study Start: May 16, 2017
• Primary Completion: June 18, 2018
• Study Completion: March 6, 2019
• Last Updated: October 23, 2019
• Results First Posted: October 23, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)