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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-002785-10
    Sponsor's Protocol Code Number:2005032
    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:2005-10-05
    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 number2005-002785-10
    A.3Full title of the trial
    Estudio en fase III, multicéntrico, doble-ciego, aleatorizado, controlado con tratamiento activo, con grupos paralelos, de no inferioridad, comparando 150 mg de Risedronato Mensual con 5mg de Risedronato Diario en el tratamiento de la osteoporosis postmenopausica evaluado a 12 y 24 meses.

    2005032 (EFC6062) (HMR4003K/3001)
    A.3.2Name or abbreviated title of the trial where available
    MERIT-OP
    A.4.1Sponsor's protocol code number2005032
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorProcter & Gamble Pharmaceuticals Inc
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameRisedronate sodium 150 mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNrisedronic acid
    D.3.9.1CAS number 115436-72-1
    D.3.9.2Current sponsor codeNE-58095
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Actonel/Optinate 5mg film coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI-AVENTIS SAU
    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.3.1Product nameActonel 5mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNrisedronic acid
    D.3.9.1CAS number 115436-72-1
    D.3.9.2Current sponsor codeNE-58095
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    mujeres con osteoporosis postmenopáusica.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es estudiar la eficacia de un régimen de dosificación mensual de dosis única (150 mg mensuales, referido como Régimen Mensual en este protocolo) de risedronato, en comparación con el régimen de dosificación diario estándar (5 mg diarios, referido como Régimen Diario en este protocolo) de risedronato, para evaluar la no inferioridad del Régimen Mensual respecto al Régimen Diario, determinado por el porcentaje de cambio desde la Basal en la DMO de la columna lumbar a los 12 meses en mujeres con osteoporosis postmenopáusica.
    E.2.2Secondary objectives of the trial
    •cambio desde la Basal en la DMO de la columna lumbar en el Mes 12.
    •cambio y porcentaje de cambio desde la Basal en la DMO de la columna lumbar en los Meses 6, 24 y en el punto final -“endpoint”
    •cambio y porcentaje de cambio desde la Basal en DMO del fémur proximal total, cuello femoral, y trocanter en los Meses 6, 12, 24 y “endpoint”
    •cambio y porcentaje de cambio desde la Basal en marcadores de resorción ósea, y formación ósea en los Meses 3, 6, 12, 24 y “endpoint”
    •número de pacientes con al menos una nueva fractura del cuerpo vertebral en los Meses 12, 24 y “endpoint”
    •cambio desde la Basal en los resultados comunicados por la paciente en los Meses 12 y 24
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    a)ser mujer, en régimen ambulatorio, y de 50 años de edad o mayor;
    b)estar en buena salud general
    c)ser postmenopáusicas (≥5 años desde la última menstruación, natural o quirúrgica).
    d)tener al menos 3 cuerpos vertebrales de la columna lumbar evaluables (L1-L4), sin fracturas o enfermedad degenerativa;
    e)cumplir uno de los siguientes criterios de DMO de columna lumbar:
    •tener DMO de columna lumbar (L1-L4) menor de 0,772 g/cm2 (Hologic) o 0,880 g/cm2 (Lunar), correspondiente a una DMO de más de 2,5 DE por debajo del valor medio en mujeres adultas jóvenes, o
    •tener DMO de columna lumbar (L1-L4) menor de 0,827 g/cm2 (Hologic) o 0,940 g/cm2 (Lunar), correspondiente a una DMO de más de 2,0 DE por debajo del valor medio en mujeres adultas jóvenes, y al menos una fractura de cuerpo vertebral prevalerte (T4-L4);
    f)desear y ser capaz de dar el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    a)cualquier enfermedad previa o actual clínicamente significativa.
    b)abuso de alcohol,
    c)abuso de fármacos de prescripción o ilegales
    d)cualquier condición o enfermedad que pueda interferir con la evaluación de DMO de columna lumbar determinada en una radiografía de Selección por un radiólogo en el centro de radiografías central,
    e)prótesis de cadera bilateral;
    f)antecedentes de hiperparatiroidismo, a menos que se haya corregido quirúrgicamente y con concentraciones de calcio en suero normal durante al menos 12 meses antes del reclutamiento;
    g)hiperparatiroidismo no controlado u osteomalacia actual en el momento del reclutamiento;
    h)cualquier antecedente de cáncer durante los 5 años anteriores, excepto para carcinoma de células basales y carcinoma de células escamosas dérmicas con remisión documentada de 6 meses. Las pacientes con antecedentes recientes de carcinoma cervical in situ tratado con éxito, no se excluirán a menos que tengan remisión documentada de 12 meses;
    i)un Índice de Masa Corporal > 32 kg/m2;
    j)cualquier reacción alérgica o anormal a bifosfonatos:
    k)utilización de cualquiera de las siguientes medicaciones durante los 3 meses desde el inicio del fármaco del estudio o utilización de cualquiera de las siguientes medicaciones durante más de 1 mes en cualquier momento durante los 6 meses previos al inicio del fármaco del estudio:
    • glucocorticoides orales ≥5 mg de prednisolona o equivalente/día; • esteroides anabólicos
    • estrógenos (orales, parche dérmico, o gel), moduladores del receptor de estrógenos selectivo
    • progestinas
    • calcitonina
    • suplementos de vitamina D (> 1.000 UI por día)
    • calcitriol, calcidiol, o alfacalcidol a cualquier dosis
    • cualquier bifosfonato
    • fluoruro (≥10 mg/día)
    • estroncio (≥ 50 mg/día)
    • PTH
    • Productos en las clases de fitoestrógenos o isoflavonas
    l)inyección depot > 12.000 UI de vitamina D en los 9 meses anteriores;
    m)determinaciones de laboratorio clínico marcadamente anormales que el Investigador se evalúan como clínicamente significativas (Apéndice I);
    n)aclaramiento de creatinina de < 30 mL/min,
    o)hipocalcemia o hipercalcemia por cualquier causa;
    p)valor de la hormona estimuladora del tiroides en suero (TSH) fuera del rango permitido de 0,38-9,99 mlU/L (0.38-9.99 µUI/ml). q)concentración de vitamina D 25-hidroxil en suero < 12 mg/mL (30 nmol/L);
    r)participación en otro ensayo clínico 30 días antes de la Selección;
    s)pocas probabilidades demostradas de finalizar el estudio y cumplir con los requisitos del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    porcentaje de cambio desde la Basal en la DMO de la columna lumbar a los 12 meses en mujeres con osteoporosis postmenopáusica.
    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 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 Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    5mg risedronate (Actonel/Optinate)
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    El estudio se considera finalizado cuando todos los pacientes completan los tratamiento y evaluaciones, de acuerdo con el protocolo.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state66
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 1068
    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 Decision2005-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-11-10
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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