Effects of a single denosumab injection on reduction of total contact cast treatment and consolidation of bone fractures caused by acute Charcot foot in patients with diabetes mellitus (CHARCOT study)

2024-518637-28-00 Therapeutic confirmatory (Phase III) Ended

End 17 Dec 2024 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ended
Participants planned 30
Countries 1
Sites 1

Charcot, diabetes

To study treatment with denosumab, a registered injectable RANKL antibody has beneficial effects on bone fracture healing and foot deformation in diabetic subjects with a Charcot foot.Time to cession of total contact cast (Days) in combination with curation of foot fractures on X ray every month and CT scan at baseline…

Key facts

Sponsor
Amsterdam UMC Stichting
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
completed 17 Dec 2024
Decision date (initial)
2024-11-01
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2024-518637-28-00
EudraCT number
2016-003594-17

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To study treatment with denosumab, a registered injectable RANKL antibody has
beneficial effects on bone fracture healing and foot deformation in diabetic subjects with a
Charcot foot.Time to cession of total contact cast (Days) in combination with curation of foot fractures on
X ray every month and CT scan at baseline, 3,6 and 9 months of the affected foot (by
independent radiologist) upon denosumab treatment in diabetes patients with radiologically
proven Charcot foot.

Secondary objectives 1

  1. Secondary objective: Changes in volume (water displacement) and foot temperature of both feet, improvement in clinical risk score as well as prevention of foot deformation (as determined by plantar pressure measurements before and after TCC) in diabetes patients with radiologically proven Charcot foot. Also plasma RANKL concentrations will be studied before/after treatment.

Conditions and MedDRA coding

Charcot, diabetes

VersionLevelCodeTermSystem organ class
20.0 LLT 10012594 Diabetes 10027433
20.0 LLT 10008408 Charcot arthropathy 10028395

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. - Radiologically proven Charcot foot (x ray, CT or MRI) - Confirmed diagnosis of either type 1 or type 2 diabetes with neuropathy - Patient is willing and able to provide written consent - Normal life expectancy

Exclusion criteria 1

  1. - Known latex allergy - Scheduled dental treatment (molar extraction) in the next year

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to cession of total contact cast (Days) in combination with curation of foot fractures (by independent radiologist) upon denosumab treatment at baseline, 3,6 and 9 months in diabetes patients with proven Charcot foot (blindly analysed by prof Maas, dept. of Radiology AMC)

Secondary endpoints 1

  1. Prevention of foot deformation (as determined by plantar pressure measurements before and in diabetes patients with radiologically proven Charcot foot. Also changes in volume (water displacement) and foot temperature of both feet as well as clinical risk score will be determined at these time points.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Denosumab

SCP101866948 · ATC

Active substance
Denosumab
Substance synonyms
AMG 162, HLX14, TVB-009, MAB-22
Route of administration
IV INFUSION
Max daily dose
60 mg milligram(s)
Max total dose
120 mg milligram(s)
Max treatment duration
9 Week(s)
Authorisation status
Authorised
ATC code
M05BX04 — DENOSUMAB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Saline

SUB20722 · Substance

Active substance
Saline
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
IV INFUSION
Max daily dose
1 ml millilitre(s)
Max total dose
1000 ml millilitre(s)
Max treatment duration
9 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC Stichting

75 Total trials 44 Recruiting 14 Ended
Academic / Non-commercial
Sponsor organisation
Amsterdam UMC Stichting
Address
De Boelelaan 1117
City
Amsterdam
Postcode
1081 HV
Country
Netherlands

Scientific contact point

Organisation
Amsterdam UMC Stichting
Contact name
M. Nieuwdorp

Public contact point

Organisation
Amsterdam UMC Stichting
Contact name
M. Nieuwdorp

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ended 30 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Ended
Amsterdam UMC Stichting
internal medicine, Meibergdreef 9, 1105 AZ, Amsterdam

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
summary of results
SUM-109898
 2025-12-08T09:41:41 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
laypersons summary of results 2025-12-08T09:41:56 Submitted Laypersons Summary of Results

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) Laypersons summary of results 1
Protocol (for publication) D1_protocol_2024-518637-28-00 1.4
Recruitment arrangements (for publication) This aspect was assessed by National Competent Authority 1
Subject information and informed consent form (for publication) Informed consent CHARCOT Trial study definitief 1.1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPc denosumab 1
Summary of results (for publication) summary_charcot 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-04 Netherlands Acceptable
2024-11-01
 2024-11-01