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    Summary
    EudraCT Number:2013-002648-10
    Sponsor's Protocol Code Number:ADDI-D
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-002648-10
    A.3Full title of the trial
    THE EFFECT OF A DAILY AND WEEKLY ADMINISTRATION OF DIFFERENT DOSES OF CALCIDIOL ON 25(OH)D3 SERUM LEVELS AND ON MINERAL AND BONE METABOLIC MARKERS IN POSTMENOPAUSAL FEMALE SUBJECTS OVER 55 YEARS OF AGE WITH INADEQUATE LEVELS OR DEFICIT OF 25(OH)D3
    EFFETTI DELLA SOMMINISTRAZIONE GIORNALIERA E SETTIMANALE DI DIFFERENTI DOSI DI CALCIFEDIOLO SUI LIVELLI SIERICI DI 25(OH)D3 E SUI MARCATORI MINERALI E OSSEI IN DONNE IN POSTMENOPAUSA SOPRA I 55 ANNI D’ETA’ CON INADEGUATO LIVELLO O DEFICIT DI 25(OH)D3
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE EFFECT OF A DAILY AND WEEKLY ADMINISTRATION OF CALCIDIOL IN POSTMENOPAUSAL FEMALE SUBJECTS OVER 55 YEARS OF AGE
    EFFETTI DELLA SOMMINISTRAZIONE GIORNALIERA E SETTIMANALE DI CALCIFEDIOLO IN DONNE IN POSTMENOPAUSA SOPRA I 55 ANNI D’ETA’
    A.3.2Name or abbreviated title of the trial where available
    ADDI-D
    ADDI-D
    A.4.1Sponsor's protocol code numberADDI-D
    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 SponsorBruno Farmaceutici S.p.a.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBruno Farmaceutici S.p.a.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBruno Farmaceutici S.p.a.
    B.5.2Functional name of contact pointReception
    B.5.3 Address:
    B.5.3.1Street AddressVia delle Ande, 15
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00144
    B.5.3.4CountryItaly
    B.5.4Telephone number+39(0)66050601
    B.5.5Fax number+39(0)660506040
    B.5.6E-mailadriana.pignatelli@brunofarmaceutici.it
    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 DIDROGYL
    D.2.1.1.2Name of the Marketing Authorisation holderBruno Farmaceutici S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal female subjects with inadequate levels or deficit of 25(OH)D3
    Donne in postmenopausa con inadeguato livello o deficit di 25(oh)d3
    E.1.1.1Medical condition in easily understood language
    Postmenopausal female subjects with inadequate levels or deficit of 25(OH)D3
    Donne in postmenopausa con inadeguato livello o deficit di 25(oh)d3
    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 compare the effects on the increase of circulating levels of 25(OH)D3 of three different therapeutic regimens of Calcidiol (Didrogyl)
    Comparare gli effetti dell’incremento dei livelli circolanti di 25(OH)D3 in 3 differenti regimi terapeutici di calcifediolo (Didrogyl)
    E.2.2Secondary objectives of the trial
    To compare the effects of three different therapeutic regimens of Calcidiol (Didrogyl) on changes of serum and the urinary levels of mineral and bone biomarkers compared to baseline.
    Comparare gli effetti di tre differenti regimi terapeutici di Calcidiolo (Didrogyl) sulle variazioni rispetto al basale dei livelli sierici e urinari dei marcatori minerali e ossei.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic characteristics
    1. Caucasian
    2. Aged >55 years
    3. Postmenopausal status for female subjects (>2 years after last menstruation)

    Medical and therapeutic criteria
    4. Ambulatory (ability to walk independently)
    5. BMI <30 kg/sq.m
    6. Capable of understanding the purpose and risks of the study, fully informed and having given written informed consent (signed Informed Consent has been obtained).
    7. Life expectancy sufficient to participate in the entire course of study
    8. Vitamin D status as follows:
    a. All subjects should have 25(OH)D3 serum concentrations <30 ng/ml
    9. Intake of 1000 mg/day of calcium
    Caratteristiche demografiche:
    1. Pazienti caucasici
    2. Età >55 anni
    3. Stato di postmenopausa (>2 anni dall’ultima mestruazione)

    Criteri medici:
    4. In grado di camminare autonomamente
    5. BMI <30 kg/sq.m
    6. Capacità di comprensione dello scopo e dei rischi dello studio, totalmente informato e consenso allo studio (firma del modulo di consenso informato ).
    7. Aspettativa di vita sufficiente a partecipare all’intera durata dello studio
    8. Valori della Vitamina D:
    a. Tutti I soggetti dovrebbero avere una concentrazione sierica di 25(OH)D3 <30 ng/ml
    9. Assunzione di 1000 mg/die di calcio
    E.4Principal exclusion criteria
    General criteria
    1. Unlikely to co-operate in the study and to comply with the visits scheduled in the protocol
    2. Simultaneously participating or having participated in another clinical trial with an investigational drug within 3 months previous to the admission in this study
    3. Subjects belonging to any of the following categories: incarcerated persons, subjects in an emergency situation, subject with severe mental disorders, patients legally incapacitated.

    Medical and therapeutic criteria
    4. Progressive major illness (CVD, HIV, diabetes, active hepatitis B or C)
    5. Planned hospitalization longer than 2 weeks during the course of the study (3- months)
    6. Severe malabsorption syndrome
    7. Severe renal insufficiency (Creatinine clearance <30 ml/min for males and 0.85 times this value for females)
    8. Paget’s disease of bone
    9. Hyper- or hypo-parathyroidism
    10. Hypercalcemia
    11. Sarcoidosis
    12. Documented hypercalciuria without any calcium supplementation (>300 mg/24 hours), especially in case of history of renal lithiasis
    13. History of intolerance, allergy or hypersensitivity to Didrogyl
    14. Treatments interfering with bone and mineral metabolism:
    - Vitamin D treatment >400 IU/day in the previous month before selection or doses >10000 IU within the previous 3 months or doses >50000 IU within the previous 12 months
    - Calcitriol and alfacalcidol (above 0.25 µg/day) during the previous 6 months
    - Lithium, thiazides
    - Glucocorticoids:

    Oral long-term treatment: more than 5 mg/day equivalent prednisolone for more than 8 months during the previous year or more than 2 g equivalent prednisolone in the previous year
    Inhaled long-term treatment steroids: more than 1000 microgram/day for more than 6-months in the previous year.
    - Immunosuppressants (cyclosporine, azathioprine) within the previous year
    - Antiretroviral therapy
    - Treatments interfering with vitamin D absorption or catabolism:
    Olestra, mineral oils, orlistat, bile acid sequestrants (cholestyramine, Colestipol), cimetidine, Ketoconazol, in the previous 2 weeks.,
    Vitamin A (excluding beta-carotene) in excess of 10000 IU/day in the previous last month
    Criteri generali:
    1. Non acconsente a cooperare allo studio e a seguire le visite previste dal protocollo
    2. Partecipazione simultanea o aver partecipato ad altro studio clinico nei tre mesi precedenti il reclutamento allo studio
    3. Soggetti appartenenti alle seguenti categorie: persone detenute in carcere, persone in situazione d’emergenza, soggetti con disordini mentali, pazienti legalmente incapaci.

    Criteri medici e terapeutici:
    4. CVD, HIV, diabete, epatiti attive B o C
    5. Ospedalizzazione programmata per più di due settimane nel corso dello studio (3-mesi)
    6. Sindrome di malassorbimento acuta
    7. Insufficienza renale severa (Clearance della creatinina <25,5 ml/min )
    8. Sindrome di Paget
    9. Iper e ipo paratiroidismo
    10. ipercalcemia
    11. Sarcoidosi
    12. Documentata ipercalciuria senza alcun supplemento di calcio (>300 mg/24 ore), specialmente in caso di pazienti con una storia di litiasi renale
    13. Intolleranza, allergia o ipersensibilità al Didrogyl
    14. Trattamenti che interferiscono con il metabolismo osseo e minerale:
    - Vitamina D >400 IU/die nel mese precedente la selezione o dose >10000 IU entro i tre mesi precedenti o >50000 IU entro i 12 mesi precedenti
    - Calcitriolo e alfacalcidolo (sopra 0.25 µg/giorno) durante i precedenti 6 mesi.
    - Litio, tiazide
    - Glucocorticoidi:
    Trattamento orale a lungo termine: più di 5 mg/die di prednisolone per più di 8 mesi durante l’anno precedente o più di 2 g di prednisolone nell’anno precedente
    Trattamento inalatorio a lungo termine di steroidi: più di 1000 microgrammi/die per più di 6 mesi.
    - Immunosoppressori (ciclosporine , azatioprine) nell’anno precedente
    - Terapia antiretrovirale
    - Trattamenti che interferiscono con l’assorbimento della vitamina D o il catabolismo:
    Olestra, oli minerali, orlistat, seuqestranti degli acidi biliari (colesteramina, colestipolo), cimetidina, ketoconazolo, nelle precedenti 2 settimane
    Vitamina A (escluso beta-carotene) in quantità superiore a 10000 IU/die nel mese precedente
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy: Circulating values of 25(OH)D3 at 3 months of treatment
    Efficacia: Livelli circolanti di 25(OH)D3 a 3 mesi dal trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    Efficacy
    Serum calcium, phosphorus, creatinine, protein/albumin, ionized calcium, bone Alkaline Phosphatase (BAP), C-terminal telopeptides of type I collagen (CTX), Parathyroid Hormone (PTH), 1,25(OH)2D3, Fibroblast Growth Factor 23 (FGF 23), and vitamin D Binding Protein (D-BP) over 3 months of treatment
    Urinary (24 hr) calcium, phosphorus, creatinine, and deoxypyridinoline (DPD) over 3 months of treatment

    Safety:
    - Incidence of AEs
    - Laboratory parameters
    - Laboratory parameters of particular interest : calcemia, protein/albumin, ionized calcium,. CTX and 25(OH)D3 and 24 hr urinary calcium, creatinine, and D-PD
    Efficacia
    Calcio sierico, fosforo, creatinina, proteina/albumina, calcio ionizzato, fosfatasi alcalina ossea (BAP), C-terminal telopeptides of type I collagen (CTX), ormone paratiroide (PTH), 1,25(OH)2D3, Fibroblast Growth Factor 23 (FGF 23), e vitamin D Binding Protein (D-BP) dopo tre mesi di trattamento;
    livello di calcio (24 hr) nelle urine, fosforo, creatinina, e deossipiridinolina (DPD) dopo 3 mesi di trattamento

    Sicurezza:
    - Incidenza di AEs
    - Parametri di laboratorio
    - Parametri di laboratorio di particolare interesse: calcemia, proteina/albumina, calcio ionizzato, CTX e 25(OH)D3 e calcio urinario (nelle 24h), creatinina, e D-PD
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stesso farmaco a dosaggi differenti
    Same IMP at different dosages
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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
    LVLS
    Ultima visita dell'ultimo paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state84
    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)
    At trial end patients will be treated according the local clinical practice of the centre
    Al termine dello studio i pazienti saranno trattati in accordo alla pratica clinica locale
    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 Decision2014-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-03
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