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    Summary
    EudraCT Number:2018-003724-36
    Sponsor's Protocol Code Number:CODIF-008
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2018-003724-36
    A.3Full title of the trial
    The DENOCHARCOT trial
    Efficacy of treatment with DENOsumab of an acute CHARCOT foot in patients with diabetes. A multicenter, double-blind, randomized, placebo-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of treatment with DENOsumab of an acute CHARCOT foot in patients with diabetes.
    A.3.2Name or abbreviated title of the trial where available
    The DENOCHARCOT trial
    A.4.1Sponsor's protocol code numberCODIF-008
    A.5.4Other Identifiers
    Name:Amgen LimitedNumber:ISS 20187231
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOle Lander Svendsen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAmgen Limited
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportRegion Hovedstaden
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportGCP enhederne, Danske Regioner
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOle Lander Svendsen
    B.5.2Functional name of contact pointSponsor and Principal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressDept Endocrinology, Bispebjerg Hospital, Ebba Lunds Vej 44, entrance 60, ground floor
    B.5.3.2Town/ cityCopenhagen NV
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4521830863
    B.5.6E-mailole.lander.svendsen@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute Charcot foot (Charcot arthropathy; ICD-10: DM14.6) in patients with diabetes
    E.1.1.1Medical condition in easily understood language
    Acute Charcot foot is a rare complication to diabetes, which is presenting as a red, swollen foot with increased skin temperature, that is followed by fractures of bones deformity of the foot.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008408
    E.1.2Term Charcot arthropathy
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant outcomes in a randomized, double blind, placebo-controlled trial.

    The main objective is to assess the difference between Prolia and placebo in time from first injection of IP until the time point where the acute Charcot foot is clinically healed/in remission, ie. the temperature difference at the site maximum temperature on the affected Charcot foot is < 2 degrees Celsius compared to the similar site on the contra-lateral foot, measured using an infrared thermometer, and edema and redness of the skin has subsided – at two subsequent visits 4 weeks apart.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess the difference between Prolia and placebo in:

    Fraction of clinical healed participants at each study visit.

    Fraction of healing on X-rays and MRI (or PET/CT or bone scintigram) at the time of clinical healing and at the End of trial.

    Number of relapses (defined as need for/prescription of off- loading with cast of the Charcot foot again)

    Time without relapse (the time from clinical healing/remission to the relapse or to End of Trial at 12 months).

    Number of patients with development of complications to the acute Charcot foot, as well as number of development of foot ulcer, deformity, need for special footwear or surgery and fractures of bones in the foot, respectively.

    Changes in Bone mineral density (lumbar spine, and hip) by DXA, Markers of bone turnover (CTX and P1NP) and Markers of glycemic control (HbA1c)

    Incidence of Adverse Events and Serious Adverse Events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 18-80 years

    • Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months)

    • Diagnosed with acute Charcot foot defined as a unilateral red, swollen and warm foot, with a difference of skin temperature of more than 2 °C compared with the unaffected foot and with sign of Charcot on either x-rays of the foot, MRI, bone scintigram or PET/CT.

    • Peripheral neuropathy: Previously diagnosed and/or biothesiometri: > 25 V or lack of sensation of 10 grams monofilament on 1. toe at the acute Charcot foot.
    E.4Principal exclusion criteria
    • Duration of the acute Charcot foot for more than 3 months (at the screening visit).
    • Existing foot ulcer on the affected foot
    • Previous acute or chronic Charcot of the affected foot
    • Planned surgery on the acute Charcot foot
    • Infection (cellulitis or osteomyelitis) of the affected foot (clinically and/or radiologically proven)
    • Previous midfoot or proximal to mid foot amputation of the affected foot
    • Hypocalcemia (Serum Calcium <2.1 mmol/L or Calcium ion < 1.12 mmol/L)
    • Vitamin D deficiency (Serum 25-hydroxyvitamin D < 50 nmol/L)
    • Renal failure (serum creatinine >200 mmol/L or eGFR < 30 ml/min).
    • Treatment with Denosumab within the last 12 months.
    • Have a known hypersensitivity to Denosumab
    • History of osteonecrosis of the jaw.
    • Poor oral hygiene, which is defined as within 3 months of a tooth extraction, dental implants or mandibular surgery
    • Planned mandibular surgery or dental implants within the next 12 months.
    • Prior non-traumatic vertebral fracture
    • Treatment with medication known to affect bones within the last 12 months (such as bisphosphonates, Forsteo®, calcitonin, Protelos®, selective estrogen receptor modulators, glucocorticoids and sex hormones)
    • Active or chronic liver disease
    *Chronic liver disease is defined as clinical history of decompensated chronic liver disease (ascites, encephalopathy or variceal bleeding), *Acute Liver disease is defined as an INR of > 1.5 (in the absence of the use of Warfarin) and AST and ALT > 2 x ULN
    • History of inflammatory arthropathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthropathy)
    • Pre-existing medical condition judged to preclude safe participation in the study
    • Current treatment with cytotoxic drugs or with systemically administered glucocorticoids
    • Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol
    • Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods. The following contraceptive products are considered to be safe: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).
    • .
    • Likely inability to comply with the visits because of planned activity
    • Use of any investigational product with the last month.
    • Use of any drug or any other reason which in the Investigator’s opinion could interfere with the outcome of the treatment of the acute Charcot foot.
    • Cancer, or any clinically significant disease or disorder, except for conditions associated to the diabetes, which in the Investigator’s opinion could interfere with the results of the trial
    E.5 End points
    E.5.1Primary end point(s)
    Time from first injection of IP until the time point where the acute Charcot foot is clinically healed/in remission, ie. the temperature difference at the site maximum temperature on the affected Charcot foot is < 2 degrees Celsius compared to the similar site on the contra-lateral foot, measured using an infrared thermometer, and edema and redness of the skin has subsided – at two subsequent visits 4 weeks apart
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each study visit after first injection of IP
    E.5.2Secondary end point(s)
    Fraction of clinical healed participants at each study visit.

    Fraction of healing on X-rays and MRI (or PET/CT or Scintigram) at the time of clinical healing and at the End of trial.

    Number of relapses (defined as need for/prescription of off- loading with cast of the Charcot foot again)

    Time without relapse (the time from clinical healing/remission to the relapse or to End of Trial at 12 months).

    Number of patients with development of complications to the acute Charcot foot, as well as number of development of foot ulcer, deformity, need for special footwear or surgery and fractures of bones in the foot, respectively.

    Changes in Bone Mineral Density (lumbar spine,and hip) by DXA, markers of bone turnover (CTX and P1NP) and markers of glycemic control (HbA1c)

    Incidence of Adverse Events and Serious Adverse Events  
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each study visit for some of the endpoints, and at baseline, at clinical healing, and at end of trial (12 months after first IP injection) for other endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 26
    F.4.2.2In the whole clinical trial 38
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-24
    P. End of Trial
    P.End of Trial StatusOngoing
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