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    Summary
    EudraCT Number:2017-004028-31
    Sponsor's Protocol Code Number:HIDR-0217/OST
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-11-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-004028-31
    A.3Full title of the trial
    Effect of the administration of different Hidroferol® Soft Gelatine Capsules (calcifediol) and cholecalciferol (Dibase®) regimens on 25(OH)D levels and markers of bone remodelling in postmenopausal women with 25(OH)D deficiency.
    Influence of clinical and genetic factors in the osteoporotic and non-osteoporotic population.
    Efecto de la administración de diferentes regímenes de tratamiento de Hidroferol® Cápsulas de Gelatina Blanda (calcifediol) y colecalciferol (Dibase®) en los niveles de 25(OH)D y marcadores de remodelado óseo en mujeres postmenopáusicas con deficiencia de 25(OH)D.
    Influencia de factores clínicos y genéticos en la población osteoporótica y no-osteoporótica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Soft Gelatine Capsules (calcifediol) and cholecalciferol (Dibase®) in postmenopausal women with vitamin D deficiency.
    Influence of clinical and genetic factors in the osteoporotic and non-osteoporotic population.
    Efecto de la administración de diferentes regímenes de tratamiento de Hidroferol® Cápsulas de Gelatina Blanda (calcifediol) y colecalciferol (Dibase®) en mujeres postmenopáusicas con deficiencia de vitamina D.
    Influencia de factores clínicos y genéticos en la población osteoporótica y no-osteoporótica.
    A.4.1Sponsor's protocol code numberHIDR-0217/OST
    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 SponsorFAES FARMA S.A
    B.1.3.4CountrySpain
    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 supportFAES FARMA S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFAES FARMA S.A
    B.5.2Functional name of contact pointNieves Fernandez
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Autonomía 10
    B.5.3.2Town/ cityLeioa (Bizkaia)
    B.5.3.3Post code48940
    B.5.3.4CountrySpain
    B.5.4Telephone number003494481 83 00
    B.5.6E-mailnfernadez@faes.es
    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 HIDROFEROL
    D.2.1.1.2Name of the Marketing Authorisation holderHIDROFEROL
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule, soft
    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 INNCALCIFEDIOL
    D.3.9.1CAS number 19356-17-3
    D.3.9.4EV Substance CodeSUB06045MIG
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 holderDIBASE
    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 liquid
    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 INNCHOLECALCIFEROL
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)
    D.3.9.4EV Substance CodeSUB11818MIG
    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 women with 25 (OH) D deficiency
    Mujeres postmenopaúsicas con deficiencia de 25 (OH)D
    E.1.1.1Medical condition in easily understood language
    Postmenopausal women with vitamin D deficiency
    Mujeres postmenopausicas con deficit de vitamina D
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10047626
    E.1.2Term Vitamin D deficiency
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety in postmenopausal women with vitamin D deficiency, with or without osteoporosis, of the long-term treatment with Hidroferol® Soft Gelatine Capsules (SGC) in the correction and maintenance of normal values of vitamin D comparing with the approved regimen and with the treatment recommended by the current European Guidance .
    Evaular la eficacia y seguridad en mujeres postmenopáusicas con deficiencia de vitamina D, con o sin osteoporosis, del tratamiento a largo plazo con Hidroferol® Cápsulas de Gelatina Blandas (CGB) en la corrección y mantenimiento de valores normales de vitamina D comparado con el régimen de tratamiento aprobado actualmente y con el tratamiento recomendado por las Guías Europeas.
    E.2.2Secondary objectives of the trial
    To assess the percentage of patients achieving 25(OH)D levels above 30 ng/mL at 1, 8, and 12 months of treatment in each of the treatment groups investigated.
    Other:
    -Time to achieve the treatment goal (> 30 ng/mL) i
    -Mean change in 25(OH)D levels at 1, 4, 8, and 12 months
    -Change in levels of bone resorption markers CTX and P1NP in the stratum of non-osteoporotic patients at baseline, 4, 8, and 12 months
    -Change in levels of PTH at screening, 1, 4, 8 and 12 months
    -Modulation of 25(OH)D levels according to phenotype taking into account the age and obesity (BMI and abdominal circumference).
    -Modulation of 25(OH)D levels according to vitamin D receptor genotypes and mechanisms of vitamin D transport and metabolism. Polymorphisms of the following will be assessed: 1α-hydroxylase enzyme, Vitamin D catabolism, Vitamin D receptor and transporting protein.
    -Treatment adherence during the 12 months
    -Assessment of the free fraction and vitamin D metabolites in serum.
    Evaluar el porcentaje de pacientes que alcanzan niveles de 25(OH)D por encima de 30ng/ml a los 1, 8 y 12 meses
    Otros:
    Tiempo en alcanzar el objetivo de tratamiento
    Variación media de los niveles de 25(OH)D a los 1,4,8 y 12 meses
    Variación de los niveles de marcadores de remodelado óseo CTX y P1NP en el estrato de pacientes no osteoporóticas en visita basal, 4,8 y 12 meses
    Variación de los niveles de calcio total, PTH, albúmina, fósforo y fosfatasa alcalina en la visita de selección, 1, 4, 8 y 12 meses
    Variación de los niveles de 25(OH)D de acuerdo con el fenotipo, teniendo en cuenta la edad y obesidad
    Variación de los niveles de 25(OH)D en función de los genotipos de losreceptores, mecanismos de transporte y metabolismo de la vitamina D.
    -Adherencia al tratamiento durante los 12 meses
    -Evaluación de la fracción libre y los metabolitos de la vitamina D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Postmenopausal women: amenorrhea for more than 6 months or FSH above 30 IU/l with estradiol below 30 pg/mL.
    -Women with vitamin D deficiency (25-hydroxycholecalciferol levels < 20 ng/mL).
    -Postmenopausal patients who are NON-OSTEOPOROTIC and are NOT receiving treatment with drugs affecting bone metabolism OR postmenopausal patients who are OSTEOPOROTIC and receiving treatment WITH antiresorptives, biphosphonates or denosumab.
    -Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
    -Mujeres postmenopáusicas: amenorrea desde hace más de 6 meses o FSH por encima de 30 IU/l con estradiol por debajo de 30 pg/mL.
    -Mujeres con deficiencia de vitamina D (25(OH)D < 20 ng/mL).
    -Mujeres postmenopáusicas que no son osteoporóticas y no están recibiendo tratamiento con fármacos que afecten al metabolismo óseo o mujeres postmenopáusicas osteoporóticas recibiendo tratamiento con antiresrotivos, bifosfonatos o denosumab.
    -Firma del consentimiento informado donde se indica que el paciente ha entendido el propósito del estudio y los procedimientos requeridos para el estudio y están de acuerdo en participar en el estudio y cumplir con los procedimientos y restricciones del ensayo.
    E.4Principal exclusion criteria
    -Patients taking drugs that modify vitamin D levels: phenobarbital, phenytoin, rifampicin, antiretrovirals (tenofivir, adenofivir), long-term corticosteroids, orlistat and cholestiramine.
    -Patients taking any nutritional supplement such as vitamin complexes.-Patients diagnosed with malabsorption
    -Patients with kidney stones
    -Patients with primary hyperparathyroidism
    -Patients with hyperthyroidism
    -Patients with hypercalcemia
    -Patients with creatinine clearance < 30 mL/min
    -Patients with tumours within the last 5 years
    -Patients who have a history with evidence of diseases, medications, laboratory abnormalities or any other circumstance that could alter the conduct of the study
    -Patients who are allergic to any of the ingredients of the medication (E-110 color, gelatine, glycerol, titanium, refined olive oil)
    -Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the screening or is currently enrolled in an investigational interventional study.
    -Pacientes tomando fármacos que alteren los niveles de vitamina D: fenobarbital, fenitoina, rifampicina, antiretrovirales, corcicosteroides largo plazo, orlistat y colestiramina.
    -Pacientes tomando algún suplemento nutricional como complejos vitamínicos.
    -Pacientes diagnosticados con malabsorción. -Pacientes con piedras en los riñones. -Pacientes con hiperparatiroidismo primario. -Pacientes con hipertiroidismo.
    - Pacientes con hipercalcemia.
    - Pacientes con aclaramiento de la creatinina < 30 mL/min
    -Pacientes con tumores en los 5 años previos.
    -Pacientes con enfermedades, fármacos, valores anormales de laboratorio o cualquier otra circunstancia que pueda alterar el desarrollo del estudio. -Pacientes alérgicos a alguno de los ingredientes de la medicación: etanol, triglicéridos de cadena media, glicerina vegetal, sorbitol (E-420), dióxido de titanio (E-171), colorante , agua purificada, y/o aceite de oliva refinado) -Pacientes que hayan recibido un fármaco en investigación (incluyendo vacunas) o han usado un dispositivo medico invasivo en los últimos 30 díasprevios al inicio de la fase de selección o están actualmente participando en otro ensayo clínico.
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of patients achieving 25(OH)D levels above 30 ng/mL at 4 months of treatment
    orcentaje de pacientes que alcanzan niveles de 25(OH)D por encima de 30ng/ml a los 4 meses de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months of treatment
    4 meses de tratamiento
    E.5.2Secondary end point(s)
    - Percentage of patients achieving 25(OH)D levels above 30 ng/mL at 1, 8, and 12 months of treatment.
    - Mean change from screening of 25(OH)D serum concentrations at 1, 4, 8, and 12 months of treatment.
    -Time to achieve treatment objective.

    Bone and Mineral Metabolism Study:
    - Serum concentrations of total serum calcium (tCa), PTH, albumin, phosphorus and total alkaline phosphatase will be assessed at screening and at 1, 4, 8, and 12 months.

    Bone Remodelling Marker Study:
    - Serum concentrations of P1NP and β-CTX at baseline, 4, 8, and 12 months will be measured in non-osteoporotic patients.

    Genetic Study:
    On baseline visit, patients who have consented to perform a genetic study, a whole blood sample will be obtained and frozen to -20ºC to determine polymorphisms related to vitamin D levels.

    Study on Dietary Calcium Consumption and Obesity Parameters:
    Dietary calcium consumption at baseline and at 4, 8, and 12 months by a validated questionnaire.
    Body mass index (BMI) and abdominal circumference at baseline and at 12 months.

    Free fraction of 25-hydroxyvitamin D and vitamin D metabolites:
    Assessment of the free fraction of 25-hydroxyvitamin D and vitamin D metabolites in serum at baseline, 4 and 12 months.
    -Porcentaje de pacientes que alcanzan niveles de 25(OH)D por encima de 30ng/ml a los 1, 8 y 12 meses de tratamiento.
    -Tiempo en alcanzar el objetivo de tratamiento (>30ng/ml) .
    -Variación de los niveles de 25(OH)D a los 1,4,8 y 12 meses de tratamiento.
    Estudio del metabolismo óseo:
    - Concentración en suero de calcio total, PTH, albúmina, fósforo y fosfatasa alcalina a los 1, 4, 8 y 12 meses de tratamiento.
    Estudio de marcadores de remodelado óseo:
    - Concentración en suero de P1NP y β-CTX en la visita basal, 4, 8, y 12 meses de tratamiento en pacientes no osteoporóticas.
    Estudio genético:
    En la visita basal, a los pacientes que hayan consentido participar en un estudio genético, se les extraerá una muestra de sangre y se congelará a - 80oC para determinar los polimorfismos relacionados con los niveles de vitamina D (1-hidroxilasa, catabolismo de la vitamina D, receptores de la vitamina D y proteína transportadora).
    Estudio del consumo de calcio y parámetros de obesidad:
    -El consumo de calcio en la dieta se determinará mediante la adaptación de un cuestionario validado en la visita basal, 4, 8 y 12 meses de tratamiento. -El índice de masas corporal y la circunferencia abdominal se determinará en la visita basal, 4 y 12 meses de tratamiento.Fracción libre y metabolitos de la vitamina D:
    La evaluación de la fracción libre y de los metabolitos de la vitamina D se realizará en la visita basal, a los 4 y a los 12 meses.
    Adherencia al tratamiento:
    Administración de ambos tratamientos mensualmente (cápsula de gelatina blanda y solución oral) durante el estudio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 and 12 moths
    A los 4 y 12 meses
    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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 del ultimo paciente
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state175
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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
    Ninguno
    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 Decision2017-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
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