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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03174366
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Western University of Health Sciences

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.


Condition or disease Intervention/treatment Phase
Charcot Joint of Foot Drug: Denosumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : March 29, 2018
Estimated Study Completion Date : March 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: Intervention Group, receiving medication
Subjects in this group will be receiving medication (denosumab)
Drug: Denosumab
Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 year ]
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]


Secondary Outcome Measures :
  1. Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months. [ Time Frame: 6 months ]
    Change in skin temperature difference in degrees Celsius between the affected and non-affected limb at 6 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174366


Locations
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United States, California
Western University of Health Sciences
Pomona, California, United States, 91711
Sponsors and Collaborators
Western University of Health Sciences

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Responsible Party: Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT03174366     History of Changes
Other Study ID Numbers: 20159178
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Arthropathy, Neurogenic
Joint Diseases
Musculoskeletal Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs