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    Summary
    EudraCT Number:2020-002934-34
    Sponsor's Protocol Code Number:2020-AKA
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-03
    Trial results View 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 number2020-002934-34
    A.3Full title of the trial
    The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal women
    Betydning af melatoninbehandling til postmenopausale kvinder: Effekt på knogler, marv, søvnkvalitet og karstivhed
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of melatonin treatment on bone, marrow, sleep and arterial stiffness in postmenopausal women
    Betydningen af melatoninbehandling til ældre kvinder: Effekt på knogler, marv søvn og karstivhed.
    A.3.2Name or abbreviated title of the trial where available
    Betydningen af melatoninbehandling til ældre kvinder: Effekt på knogler, marv søvn og karstivhed.
    A.4.1Sponsor's protocol code number2020-AKA
    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 SponsorAarhus University Hospital, dept. of Diabetes and Hormonal diseases
    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 supportDiabetes og Hormonsygdomme
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnne Kristine Amstrup
    B.5.2Functional name of contact pointKlinik for knogleskørhed
    B.5.3 Address:
    B.5.3.1Street AddressPalle Juul-Jensens Boulevard 99
    B.5.3.2Town/ cityAarhus N
    B.5.3.3Post code8200
    B.5.3.4CountryDenmark
    B.5.6E-mailannekristineamstrup@gmail.com
    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 No
    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.3.1Product nameMelatonin
    D.3.2Product code Mt10
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMelatonin
    D.3.9.1CAS number 73-31-4
    D.3.9.3Other descriptive nameMELATONIN
    D.3.9.4EV Substance CodeSUB14496MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoporosis
    Knogleskørhed
    E.1.1.1Medical condition in easily understood language
    Osteoporosis
    Knogleskørhed
    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 PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Changes in gene expression in mesenchymal stem cells
    Ændringer i genekspressionen i mesenchymalcellerne
    E.2.2Secondary objectives of the trial
    Changes in blood pressure and arterial stiffness
    Changes in quality of sleep
    Changes in biochemical markers
    Changes in BMD and bodycomposition
    Ændringer i døgnblodtryk samt PVW
    Ændringer i søvnkvalitet
    Ændringer i knogleomsætning, calciumhomeostase, glukose/lipidmetabolisme (biokemi)
    Ændringer i BMD i ryg og hofte (DXA)
    Ændringer i kropssammensætning (DXA)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Postmenopausal women aged 55-75 years.
    Written consent to participate
    • Kvinder mellem 55-75år
    • Postmenopausal (ikke haft menstruation i et år)
    • Skriftligt samtykke samt fuldmagt efter mundtlig og skriftlig information.
    E.4Principal exclusion criteria
    • Allergy towards study medicine
    • Allergy towards local anesthesia
    • Severely impaired renal function (eGFR <59 ml/l).
    • Treatment with antiresorptives within 5 years
    • Treatment with postmenopausal hormons within the last 2 years
    • Systemic treatment with glucocorticoids (duration >30 days) within the last year
    • Severely impaired hepatic function (Plasma alanine aminotransferase
    (ALAT) and/or alkaline phosphatase more the dobbed compared to upper limit of reference value.
    • Hypercalcemia (p-ion calcium > 1.32 nmol/l)
    • Previous or present malignancies (except a treated skin cancer that is not melanoma or treated carcinoma in situ, 2 years since last therapy).
    • Diseases affecting the calcium homeostasis including thyroid diseases.
    • Coagulationsfactor PP <0,6
    • Regular use of medicine affecting the calciumhomeostasis; including diuretics, fenemal, lithium, antiepileptica.
    • SSRI-product with fluvoxamin
    • Treatment with hypnoticas
    • Treatment with beta-blocks
    • Ongoing treatment with melatonin
    • Continuously treatment with rifampicin
    • Severe malabsorption syndrome including gastric or intestinal resection.
    • Alcohol or drug abuse.
    • Smokers
    • Major medical or social problems that will be likely to preclude participation for 3 months.
    • Allergi over for indholdsstoffer i studiemedicinen.
    • Indtagelse af antiresorptiv eller knogleopbyggende farmaka indenfor de sidste 5 år
    • Systemisk behandling med postmenopausal hormonsubstitution inden for de sidste 2 år
    • Systemisk prednisolonbehandling (>30 dage) inden for det sidste 1 år

    • Diagnostiseret og behandlet for aktiv malign lidelse inden for de sidste 2 år. Fraset er ukompliceret planocellulært karcinom.
    • eGFR <59
    • Hypercalcæmi (P-ion calcium > 1,32 mmol/l).
    • Malabsorption, herunder ventrikel/tarmresektion.
    • Nedsat leverfunktion (basisk fosfatase og ALAT mere end fordoblet i forhold til den øvre værdi i reference intervallet).
    • INR>1,5
    • Svære medicinske eller sociale problemer, som gør det usandsynligt at deltageren kan gennemføre undersøgelsen.
    • Sygdom (ubehandlet) som vides at kunne påvirke calciumhomeostasen, herunder ubehandlet thyreoideasygdom.
    • Fast indtag af medicin med kendte virkninger på calciumhomeostasen, herunder diuretika, fenemal, lithium, antiepileptika.
    • SSRI-produkter indeholdende fluvoxamin.
    • I behandling med hypnotika
    • I behandling med beta-blokker
    • I behandling carbamazepin
    • Langvarig behandling med rifampicin
    • Igangværende forbrug af melatonin
    • Rygere
    • Misbrug af alkohol (>14 genstande/uge for kvinder)
    • Indtagelse af euforiserende stoffer.
    • Manglende evne til at læse/forstå patientinformation.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in gene expression in mesenchymal stem cells
    E.5.1.1Timepoint(s) of evaluation of this end point
    2023
    E.5.2Secondary end point(s)
    Changes in blood pressure and arterial stiffness
    Changes in quality of sleep
    Changes in biochemical markers
    Changes in BMD and bodycomposition
    E.5.2.1Timepoint(s) of evaluation of this end point
    2023
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The inclusion ends when 40 study subjects are included. The trial ends at the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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 Decision2020-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-28
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