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    Summary
    EudraCT Number:2013-001222-26
    Sponsor's Protocol Code Number:2013-1
    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:2013-07-09
    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 number2013-001222-26
    A.3Full title of the trial
    Markers of bonestatus in Diabetes Mellitus patients (type 1 and type 2) and
    the effect of antiresorptive treatment on glycemic markers.
    Markører for knoglestatus hos Diabetes Mellitus patienter (type 1 og type
    2) og effekt af antiresorptiv behandling på glykæmiske markører.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Markers of bone in diabetics and the effect of bone treatment.
    Markører for knoglestatus hos diabetikere og effekten af knoglebehandling.
    A.3.2Name or abbreviated title of the trial where available
    Diabone2
    A.4.1Sponsor's protocol code number2013-1
    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 SponsorAalborg University Hospital
    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 supportCARING (EU)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAalborg University Hospital
    B.5.2Functional name of contact pointDepartment of endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressMølleparkvej 4
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.6E-mailjakolind@rm.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 Alendronat Teva (in the study the effect of Alendronate is examined and there may be switched between types)
    D.2.1.1.2Name of the Marketing Authorisation holderTeva
    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.3.1Product nameAlendronat
    D.3.2Product code Alendronate
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    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 INNalendronic acid / colecalciferol
    D.3.9.1CAS number 121268-17-5
    D.3.9.3Other descriptive nameALENDRONIC ACID (AS SODIUM ALENDRONATE)
    D.3.9.4EV Substance CodeSUB91254
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 placeboCapsule
    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
    Diabetes Mellitus and Osteopenia/Osteoporosis
    Diabetes Mellitus and Osteopeni/Osteoporose
    E.1.1.1Medical condition in easily understood language
    Diabetes and bone fragility
    Sukkersyge og knogleskørhed
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of Alendronate on bone markers and glycemic
    markers.
    At undersøge effekten af Alendronat på knoglemarkører og glykæmiske
    markører.
    E.2.2Secondary objectives of the trial
    To compare type 1 and type 2 diabetes. And to compare different
    methods of assesing bone in diabetics.
    At sammenligne type 1 og type 2 diabetikere. Samt at sammenligne
    forskellige metoder til at vurdere knoglevæv blandt diabetikere.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Type 1 diabetes / type 2 diabetes
    • Age ≥ 50 år.
    • Same medical diabetes treatment the last six months (dose changes
    is allowed)and HbA1c changes on ± 1 in the same period.
    • HbA1c level≥ 6,7% in the last six months.
    • Body mass index (BMI) between 19 og 35.
    • DXA T-score: -3,5 til -0,5.
    • Type 1 diabetes / type 2 diabetes
    • Alder ≥ 50 år.
    • Uændret medikamentel behandling af diabetes gennem de seneste
    seks måneder (ingen præparat skift, mindre dosis ændringer tilladt),
    samt HbA1c udsving på ± 1 i samme periode.
    • HbA1c niveau ≥ 6,7% (50 mmol/L) gennem de seneste seks måneder.
    • Body mass index (BMI) mellem 19 og 35.
    • DXA T-score: -3,5 til -0,5.
    E.4Principal exclusion criteria
    • HbA1C > 10%
    • Pregnancy.
    • Metal implanted at ancle and wrist at all four ekstremities.
    • Treatment by: Antiresorptives (inkl. HRT) or bone anabolic drugs,
    glucocorticoids, lithium og anticonvulsives.
    • Patients with bone disease different from Osteoporosis.
    • Vertebral fraktur synlig ved VFA.
    • Patients with kidney disease defined by eGFR < 50.
    • Other significant medical disease in unstable phase (like cancer or
    hyperthyroidism)
    • Heart failure in NYHA class IV.
    • Previous allergic reactions to the trial drug.
    • Previous allergic reactions to tetracyklin.
    • Abnormities in esophagus and other factors, which may delay the transit tim in the esophagus.
    • Unable to stand or sit for 30 consecutive minutes.
    • The investigator considers the patient unfit to participate.
    • Patient with no understanding of the extent of the trial.
    • HbA1C > 10%
    • Graviditet.
    • Metal indopereret på ankel og håndledsniveau på alle fire
    ekstremiteter.
    • Patienter i behandling med: Antiresorptive (inkl. HRT) eller
    knogleanabole lægemidler, glukokortikoid, litium og anticonvulsiva.
    • Patienter kendt med anden knoglesygdom end osteoporose.
    • Vertebral fraktur synlig ved VFA.
    • Patient med nyresygdom inklusiv diabetisk nefropati, der defineres
    ved eGFR < 50. Patienter med mikroalbuminuri ekskluderes ikke.
    • Anden betydende medicinsk sygdom i ustabil fase (f.eks. cancer,
    stofskiftesygdom).
    • Hjerteinsufficiens i NYHA klasse IV.
    • Allergi overfor et af indholdsstofferne i forsøgsmedicinen.
    • Allergi over for tetracyklin.
    • Abnormiteter i oesophagus og andre faktorer, som forsinker spiserørstømning, såsom striktur eller akalasi.
    • Manglende evne til at stå eller sidde oprejst i mindst 30 minutter.
    • Patient skønnes af investigator uegnet til at deltage i studiet.
    • Patient uden forståelse af patientinformationen og omfanget af
    undersøgelser.
    E.5 End points
    E.5.1Primary end point(s)
    HbA1c and BMD
    HbA1c og BMD
    E.5.1.1Timepoint(s) of evaluation of this end point
    HbA1c is evaluated after one and three months and one and two years
    (the analyses may be done at the end of the study after two years).
    BMD is measured after one and two years.
    HbA1c bliver målt efter en og tre måneder samt et og to år (analyserne
    kan blive udført ved afslutningen af studiet efter to år).
    BMD bliver målt efter et og to år.
    E.5.2Secondary end point(s)
    Insulin, plasmaglucose, HOMA-IR, hs-CRP, AGE markers, lipids,
    adiponectin, PTH, 25 og 1,25 vitamin D, bone specific alkaline
    phosphatase, FSH, LH, testestoron/østradiol, creatinine, GFR, FGF23,
    sclerostin, osteocalcin, ucOC, P1NP, PICP, CTX, osteoprotegrin, RANKL
    og pentosidine. Urine albumin/creatinine ratio and urine bone markers.
    HRpQCT scan results.
    Analysis results by fat tissue-, muscle tissue- and bone biopsies.
    Life style questionnaire including diet and physical activity.
    HbA1C, faste-insulin, faste-plasmaglukose, HOMA-IR, hs-CRP, AGE
    XML File Identifier: oRn9kfjng2GnCPFTqgunVNDlPxc=
    Page 11/20
    markører, lipider, adiponectin, PTH, 25 og 1,25 vitamin D, knoglespecific
    basisk fosfatase, FSH, LH, testestoron/østradiol, kreatinin, GFR, FGF23,
    sclerostin, osteocalcin, ucOC, P1NP, PICP, CTX, osteoprotegrin, RANKL
    og pentosidin. Urin albumin/creatinin ratio og knoglemarkører i urinen.
    HRpQCT skanningsresultater.
    Analyse resultater af fedtvævs-, muskelvævs- og knoglevævs biopsier.
    Livsstils spørgeskema indeholdende blandt andet diæt og fysisk aktivitet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be evaluated by the end of the trial.
    However scanning results and muscle and fat biopsy results may be
    evaluated after one year. Like some biochemical may be evaluated after
    one and three months and one year like the primary endpoint HbA1c.
    The questionnaire will be filled out and evaluated at baseline, 1 month, 3 months, 1 year and 2 years.
    De sekundære endepunkter vil blive evalueret ved afslutningen af
    studiet. Dog kan scanning og muskelvævs- og fedtvævs biopsi
    resultaterne blive evalueret efter et år. Nogle biokemiske markører kan
    blive evalueret efter 1 og 3 mdr og 1 år.
    Spørgeskemaet vil blive udfyldt og evalueret ved baseline, efter 1 og måneder samt 1 og 2 år.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 trial4
    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 concerned3
    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 Yes
    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 end of the trial is at the visit of the last participant after two years.
    Afslutningen af studiet er ved sidste deltagers besøg efter to år.
    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 months3
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 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 state64
    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
    Ingen - lige en kommentar til ovenstående age range. Da vi bruger
    deltagere 50 år gamle eller ældre skulle jeg tjekke to bokse af. Men det
    er ikke sikkert at det er ligeligt fordelt mellem gruppern på over/under
    65 år. Skemaet kræver dog at begge bokse udfyldes med et tal og ikke
    et interval som 0-64, hvilket jo er vores forventning mellem de to
    grupper.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Aarhus University Hospital
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Aalborg University Hospital
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Odense University Hospital
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-08
    P. End of Trial
    P.End of Trial StatusOngoing
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