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    Summary
    EudraCT Number:2013-005027-16
    Sponsor's Protocol Code Number:VitDPHPT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-17
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-005027-16
    A.3Full title of the trial
    IMPACT OF VITAMIN D SUPPLEMENTATION ON SKELETAL AND NON SKELETAL MANIFESTATIONS IN PATIENTS WITH
    PRIMARY HYPERPARATHYROIDISM SUBMITTED TO PARATHYROIDECTOMY OR FOLLOWED WITHOUT SURGERY
    Impatto della somministrazione di Vitamina D sulle manifestazioni scheletriche e non scheletriche in pazienti con Iperparatiroidismo Primario sottoposti a paratiroidectomia o seguiti clinicamente senza chirurgia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    IMPACT OF VITAMIN D SUPPLEMENTATION ON SKELETAL AND NON SKELETAL MANIFESTATIONS IN PATIENTS WITH
    PRIMARY HYPERPARATHYROIDISM SUBMITTED TO PARATHYROIDECTOMY OR FOLLOWED WITHOUT SURGERY
    Impatto della somministrazione di Vitamina D sulle manifestazioni scheletriche e non scheletriche in pazienti con Iperparatiroidismo Primario sottoposti a paratiroidectomia o seguiti clinicamente senza chirurgia.
    A.4.1Sponsor's protocol code numberVitDPHPT
    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 SponsorCASA SOLLIEVO DELLA SOFFERENZA IRCCS
    B.1.3.4CountryItaly
    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 supportDepartment of Health
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCASA SOLLIEVO DELLA SOFFERENZA IRCCS
    B.5.2Functional name of contact pointANNAMARIA CIACCIO
    B.5.3 Address:
    B.5.3.1Street AddressVIALE CAPPUCCINI
    B.5.3.2Town/ citySAN GIOVANNI ROTONDO
    B.5.3.3Post code71013
    B.5.3.4CountryItaly
    B.5.4Telephone number00390882410831
    B.5.5Fax number00390882410813
    B.5.6E-mailcomitatoetico@operapadrepio.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 DIBASE
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA
    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.3.1Product nameCOLECALCIFEROLO (VITAMINA D3)
    D.3.4Pharmaceutical form Oral drops, solution
    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
    PRIMARY HYPERPARATHYROIDISM
    IPERPARATIROIDISMO PRIMITIVO
    E.1.1.1Medical condition in easily understood language
    PRIMARY HYPERPARATHYROIDISM
    IPERPARATIROIDISMO PRIMITIVO
    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 10036693
    E.1.2Term Primary hyperparathyroidism
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect the complications of PHPT in two different groups of postmenopausal patients:
    a)asymptomatic PHPT patients (subjects not fulfilling the surgical criteria plus osteoporosis);
    b)symptomatic PHPT patients that are undergoing parathyroidectomy;
    The end points are:
    - the variation of Bone Mineral Density (BMD) measured at lumbar spine / femoral neck / forearm
    Valutare se la supplementazione con normali o relativamente alti dosaggi di VitD3 vs nessuna somministrazione possa influenzare le complicazioni del PHPT in due differenti gruppi di pazienti postmenopausa:
    a) pazienti PHPT asintomatiche (che non soddisfano i criteri chirurgici e/o con osteoporosi):
    b) pazienti PHPT da sottoporre a paratiroidectomia;
    Il parametro principale da valutare è:
     la variazione di BMD misurata alla colonna lombare/collo femorale/avambraccio
    E.2.2Secondary objectives of the trial
    - number of falls
    - clinical and morphometric vertebral fractures
    - quality of life and neuropsychological aspects
    - lipids and glucose metabolism
    - cardiac and vascular damage (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral
    valve calcification + carotid intima-media thickness + the presence of carotid plaque + the percent of carotid stenosis)
    - renal function.
    Finally measurement of Vitamin D Binding Protein (DBP) and the analysis of polymorphic variants of GC CYP2R1 CYP24A1 genes that could
    influence the effect of vitamin D supplementation, affecting the circulating levels of vitamin D, will be performed.
    - numero di cadute;
    - fratture vertebrali cliniche e morfometriche;
    - qualità della vita ed aspetti neuropsicologici;
    - metabolismo lipidico e glucidico;
    - danno cardiaco e vascolare (disfunzione diastolica, ipertrofia ventricolare sinistra, deposito di calcio nel miocardio, calcificazione aortica e della valvola mitrale, + spessore della carotide + presenza di placche carotidee + grado di stenosi della carotide)
    - funzione renale.
    - Infine verranno effettuate la misurazione della Proteina Legante la Vit D (Vitamin D Binding Protein, DBP) e l'analisi delle varianti polimorfiche dei geni GC, CYP2R1 e CYP24A1 che potrebbero influenzare l'effetto della somministrazione della Vit D, regolando i livelli circolanti di Vit D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Postmenopausal female PHPT patients aged 45-80 years.
    I criteri di inclusione sono: donne affette da iperparatiroidismo primitivo in postmenopausa di età compresa tra 45-80 anni.
    E.4Principal exclusion criteria
    familial forms of PHPT; serum calcium above 12.5 mg/dL; malignancy other than nonmelanoma skin cancer, diseases or medications known to affect mineral metabolism
    forme familiari di iperparatiroidismo primitivo; livelli sierici di calcio superiori a 12.5 mg/dL; neoplasie a parte quelle della pelle melanoma escluso, malattie o farmaci conosciuti per avere effetto sul metabolismo minerale.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect the variation of Bone Mineral Density (BMD) measured at lumbar spine / femoral neck / forearm
    Valutare se la supplementazione con normali o relativamente alti dosaggi di VitD3 vs nessuna somministrazione può influenzare la variazione di BMD misurata alla colonna lombare/collo femorale/avambraccio nei 2 gruppi di pazienti
    E.5.1.1Timepoint(s) of evaluation of this end point
    BASALINE, 12 MONTHS, 24 MONTHS
    BASALE, 12 MESI, 24 MESI
    E.5.2Secondary end point(s)
    To evaluate if normal and/or high VitD3 supplementation vs no supplementation could affect in the two groups of patients:
    - number of falls
    - clinical and morphometric vertebral fractures
    - quality of life and neuropsychological aspects
    - lipids and glucose metabolism
    - cardiac and vascular damage (diastolic dysfunction, left ventricular hypertrophy, cardiac calcium deposits in the myocardium, aortic and mitral valve calcification + carotid intima-media thickness + the presence of carotid plaque + the percent of carotid stenosis)
    - renal function.
    - Vitamin D Binding Protein (DBP) and that could together with the analysis of polymorphic variants of GC CYP2R1 CYP24A1 genes influence the effect of vitamin D supplementation, affecting the circulating levels of vitamin D
    Valutare se la supplementazione con normali o relativamente alti dosaggi di VitD3 vs nessuna somministrazione può influenzare nei 2 gruppi di pazienti:
    - numero di cadute;
    - fratture vertebrali cliniche e morfometriche;
    - qualità della vita ed aspetti neuropsicologici;
    - metabolismo lipidico e glucidico;
    - danno cardiaco e vascolare (disfunzione diastolica, ipertrofia ventricolare sinistra, deposito di calcio nel miocardio, calcificazione aortica e della valvola mitrale, + spessore della carotide + presenza di placche carotidee + grado di stenosi della carotide)
    - funzione renale.
    - Infine verranno effettuate la misurazione della Proteina Legante la Vit D (Vitamin D Binding Protein, DBP) e l'analisi delle varianti polimorfiche dei geni GC, CYP2R1 e CYP24A1 che potrebbero influenzare l'effetto della somministrazione della Vit D, regolando i livelli circolanti di Vit D
    E.5.2.1Timepoint(s) of evaluation of this end point
    BASALINE, 12 MONTHS, 24 MONTHS
    BASALE, 12 MESI, 24 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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    This study would provide novel information on relevant clinical outcomes in patients with PHPT that are not well defined and the observed results could indicate if VitD supplementation could influence:
    - the natural history of the disease
    - the recovery of the complications after surgical treatment.
    If VitD supplementation modifies the natural history of the disease, the indication for surgery might be reduced
    Questo studio potrebbe portare a nuove informazioni su rilevanti risvolti clinici in pazienti con PHPT che non sono stati ben definiti e i risultati attesi potrebbero indicare se la somministrazione con Vit D può influenzare:
    - la storia naturale della malattia;
    - il recupero delle complicazioni dopo l’intervento chirurgico.
    Se la somministrazione con Vit D modifica la storia naturale della malattia, l'indicazione alla terapia chirurgica potrebbe ridimensionarsi
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    NESSUN TRATTAMENTO
    NO TREATMENT
    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 concerned14
    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 years3
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state300
    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 THE END OF THE STUDY, THE PATIENTS WILL BE FOLLOWED TAKING VITAMIN D OR OPERATED ON ACCORDING TO THE EVOLUTION OF THEIR DISEASE AND THE RESULTS OF THIS STUDY
    Al termine dello studio i pazienti saranno seguiti con terapia con vitamina D o operati in accordo alla evoluzione della malattia ed ai risultati del presente studio
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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