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    Summary
    EudraCT Number:2017-001778-40
    Sponsor's Protocol Code Number:VITAMINA_D
    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:2017-10-02
    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 number2017-001778-40
    A.3Full title of the trial
    A Prospective Randomized Trial Comparing the Effect of 2 vitamin D supplementation regimens in elderly people after hip fracture surgery
    Ensayo clínico de bajo nivel de intervención comparando efecto 2 pautas de suplementación de vitamina D en el paciente anciano intervenido de fractura de fémur.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effect of supplementation of vitamin D deficiency in elderly people with hip fracture
    Estudio del efecto de la suplementación del déficit de vitamina D en ancianos con fractura de fémur.
    A.4.1Sponsor's protocol code numberVITAMINA_D
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03213886
    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 SponsorLeonor Cuadra Llopart
    B.1.3.4CountrySpain
    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 supportConsorci Sanitari de Terrassa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorci Sanitari de Terrassa
    B.5.2Functional name of contact pointResearch Department
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Torrebonica s/n
    B.5.3.2Town/ cityTerrassa
    B.5.3.3Post code08225
    B.5.3.4CountrySpain
    B.5.6E-maillcuadra@cst.cat
    D. IMP Identification
    D.IMP: 1
    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 HIDROFEROL
    D.2.1.1.2Name of the Marketing Authorisation holderAEMP
    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 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 INNCALCIFEDIOL
    D.3.9.1CAS number 19356-17-3
    D.3.9.2Current sponsor code53683
    D.3.9.3Other descriptive nameHIDROFEROL
    D.3.9.4EV Substance CodeSUB06045MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160000
    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
    Hip fracture and vitamin D deficiency
    Fractura de fémur y déficit de vitamina D
    E.1.1.1Medical condition in easily understood language
    Hip fracture and low levels of vitamin D in blood
    Fractura de cadera y niveles bajos de vitamina D en sangre
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 evaluate the effectiveness of 2 vitamin D supplementation regimens (calcifediol loading versus usual clinical practice) after surgery, in terms of functional recovery at 6 and 12 months follow-up, of 75-year-old patients with hip fracture and vitamin D deficiency.
    Evaluar la efectividad de 2 regímenes de suplementación de vitamina D (dosis de carga de calcifediol vs tratamiento de la práctica clínica habitual), en términos de recuperación funcional a los 6 y 12 meses de seguimiento, de pacientes 75 años intervenidos por fractura proximal de fémur con déficit de vitamina D.
    E.2.2Secondary objectives of the trial
    * To valuate, depending on the vitamin D supplementation regimen received:
    - serum levels of vitamin D (25-OH-D3) at baseline, at hospital discharge and at 3 months of follow-up.
    - improvement of strength and muscle mass at 3, 6 and 12 months of follow-up
    - Incidence of falls, fractures and mortality at 3, 6 and 12 months of follow-up.
    - To evaluate the need to use care resources (hospitalization, institutionalization, home care) at 3, 6 and 12 months of follow-up.

    * To describe the characteristics of the hospitalized and intervened females of proximal femur fracture due to fragility and low levels of vitamin D at the time of admission (incidence of vitamin D deficiency, incidence of malnutrition, degree of comorbidity, degree of autonomy for activities Basic of daily life, measured with I. Barthel); Incidence of polypharmacy; Presence of cognitive impairment ...)
    * Evaluar, en función de la pauta de suplementación de vitamina D recibida:
    - niveles séricos de vitamina D (25-OH-D3) al alta hospitalaria y a los 3 meses de seguimiento.
    - mejora de la fuerza y masa muscular a los 3, 6 y 12 meses de seguimiento
    - Incidencia de caídas, fracturas y mortalidad a los 3, 6 y 12 meses de seguimiento.
    - Evaluar necesidad de uso de recursos asistenciales (hospitalización, institucionalización, atención domiciliaria) a los 3, 6 y 12 meses de seguimiento.

    * Describir las características de las personas ingresadas e intervenidas de fractura proximal de fémur por fragilidad y niveles bajos de vitamina D en el momento del ingreso (incidencia de déficit de vitamina D; Incidencia de malnutrición; grado de comorbilidad; grado de autonomía para las actividades básicas de la vida diaria, medido con I. Barthel); incidencia de polifarmacia; presencia de deterioro cognitivo…)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged > or =75 years with hip fracture by fragility and vitamin D deficiency.
    Definitions:
    * Fracture by fragility: understood as such those that are produced by trauma of low intensity (for example, falls from the own height in standing or smaller)
    * Vitamin D deficiency: 25-OH-D3 serum levels <30 ng / mL
    Pacientes de 75 años o más con fractura proximal de fémur por fragilidad y con déficit de vitamina D.
    Definiciones:
    * fractura por fragilidad: entendiendo como tales aquellas que se producen por traumatismos de poca intensidad (por ejemplo, caídas desde la propia altura en bipedestación o menores)
    * déficit de vitamina D: niveles séricos de 25-OH-D3 < 30 ng / mL
    E.4Principal exclusion criteria
    * Presence of severe functional dependence prior to fracture of the femur (I. Barthel <35 points)
    * Diagnosis of dementia to a moderate degree (defined on the Reisberg scale as GDS-FAST> 5).
    * Medical conditions that contraindicate receiving vitamin D supplementation
    - hypercalcemia (calcemia> 10.5 mg / dL),
    - hyperparathyroidism
    - chronic renal failure with GFR <30 mL / min,
    - calcium lithiasis
    - pathologies with risk of hypercalcemia (tuberculosis, sarcoidosis ...), as well as pathologies involving intestinal malabsorption.
    - Hypersensitivity to the active substance or to any of the excipients.
    * Use of drugs that interact with the use of vitamin D and with the risk of causing hypercalcemia (phenytoin, phenobarbital, primidone, digoxin).
    * Reduced life expectancy (<12 months) due to the presence of advanced concomitant or end-of-life conditions.
    * Presencia de dependencia funcional severa previa a la fractura de fémur (I. Barthel < 35 puntos)
    * Diagnóstico de demencia en grado moderado (definido en la escala de Reisberg como GDS-FAST> 5).
    * Condiciones médicas que contraindiquen recibir suplementación de vitamina D
    - hipercalcemia (calcemia> 10,5 mg/dL),
    - hiperparatiroidismo
    - insuficiencia renal crónica con FG <30 mL/min,
    - litiasis cálcica
    - patologías con riesgo de hipercalcemia (tuberculosis, sarcoidosis...), así como patologías que impliquen malabsorción intestinal.
    - Hipersensibilidad al principio activo o alguno de los excipientes.
    * Uso de fármacos que interaccionan con el uso de vitamina D y con riesgo de provocar hipercalcemia (fenitoína, fenobarbital, primidona, digoxina).
    * Expectativa de vida reducida (< 12 meses) por presencia de enfermedades concomitantes avanzadas o en situación de terminalidad.
    E.5 End points
    E.5.1Primary end point(s)
    The treatment strategy based on the loading dose of calcifediol correlates with a functional gain (defined as a 15-point improvement in the Barthel Index) earlier. This benefit is maintained at 12 months
    La estrategia de tratamiento basada en la dosis de carga de calcifediol, se correlaciona con una ganancia funcional (definida como mejora de 15 puntos en el Índice de Barthel al alta, respecto al I. Barthel al ingreso) más temprana. Este beneficio se mantiene a los 12 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    Functional improvement will be evaluated at 3, 6 and 12 months of surgical intervention
    Se evaluará la mejora funcional a los 3, 6 y 12 meses de la intervención quirúrgica
    E.5.2Secondary end point(s)
    not applicable
    no aplicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    no aplicable
    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 Yes
    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 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
    calcifediol
    calcifediol
    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
    LVLS
    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
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state48
    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 Decision2017-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-10
    P. End of Trial
    P.End of Trial StatusOngoing
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