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

Primary Purpose

Charcot Joint of Foot

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Denosumab
Sponsored by
Western University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Charcot Joint of Foot

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Western University of Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group, receiving medication

Arm Description

Subjects in this group will be receiving medication (denosumab)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.
Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.

Full Information

First Posted
May 11, 2017
Last Updated
October 22, 2019
Sponsor
Western University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03174366
Brief Title
Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
Official Title
Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
June 18, 2018 (Actual)
Study Completion Date
March 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Charcot Joint of Foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group, receiving medication
Arm Type
Experimental
Arm Description
Subjects in this group will be receiving medication (denosumab)
Intervention Type
Drug
Intervention Name(s)
Denosumab
Intervention Description
Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.
Description
Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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: 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. 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)
Facility Information:
Facility Name
Western University of Health Sciences
City
Pomona
State/Province
California
ZIP/Postal Code
91711
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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