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

NCT ID: NCT03174366

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-16
• Study Completion Date: 2019-03-06

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group, receiving medication

Subjects in this group will be receiving medication (denosumab)

Group Type: EXPERIMENTAL

Denosumab

Intervention Type: DRUG

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

Interventions

Denosumab

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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:

1. Infection

2. Foot ulceration

3. Hypocalcemia

4. Creatinine clearance less than 30 mL/min or on dialysis

5. 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.
• History of tooth extraction or other dental surgery within the prior 6 months.
• Invasive dental work planned in the next 2 years.
• Have a known hypersensitivity to Prolia.
• Known use of a bone active medication within the 6 months prior to enrollment.
• Liver disease, defined as AST > 2.0x ULN, ALT > 2.0x ULN, TBL > 1.5x ULN.
• Malignancy within the last 5 years (except cervical carcinoma in situ or basal cell carcinoma)

• Minimum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Western University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Western University of Health Sciences

Pomona, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20159178

Identifier Type: -

Identifier Source: org_study_id