Charcot Joint of FootPhase 3NCT03174366
Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
A Phase 3 study testing Denosumab in people with Charcot Joint of Foot, run by Western University of Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, men only
- Conditions the study is for
- Charcot Joint of Foot
- What is being tested?
- Denosumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 6 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 21Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91711
About this study
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
- Being tested
- Denosumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group, receiving medication | Experimental | Subjects in this group will be receiving medication (denosumab) Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start16 May 2017
- Primary completion18 Jun 2018
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Charcot Joint of FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174366
- Sponsor's protocol ID
- 20159178
- Status last verified
- Oct 2019
- First submitted
- 11 May 2017
- Last updated
- 23 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Prolia (Denosumab) in the Treatment of Acute Charcot Neuroarthropathy
- ClinicalTrials.gov ID
- NCT03174366
- Acronym / sponsor ID
- 20159178
- Conditions
- Charcot Joint of Foot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group, receiving medication | Experimental | Drug: DenosumabSubjects in this group will be receiving medication (denosumab) |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenosumabSubjects will receive medication once following enrollment, and will be monitored for 1 year thereafter. | Drug | Intervention Group, receiving medication |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
1 secondary outcome
Change in Skin Temperature Difference in Degrees Celsius Between the Affected and Non-affected Limb at 6 Months.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Charcot Joint of Foot
RecruitingObservational study
Factors Associated With an Evolution in the Quality of Life of Diabetic Patients With Chronic, Wound-free Charcot Foot
Charcot Joint of Foot, Osteoarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab in people with Charcot Joint of Foot, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.