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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2005-005081-37
    Sponsor's Protocol Code Number:20050141
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-25
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-005081-37
    A.3Full title of the trial
    Ensayo aleatorizado, doble-ciego, para comparar la eficacia del tratamiento con Denosumab frente a alendronato sódico en mujeres posmenopáusicas con una baja densidad mineral ósea.
    A.4.1Sponsor's protocol code number20050141
    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 SponsorAmgen 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 nameDenosumab
    D.3.2Product code AMG 162
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameAbgenix l-6 CHO OPG Ligand mAb lgG2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name 'Fosamax'® Comprimidos de 70 mg (dosis semanal)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme Limited
    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 nameFosamax
    D.3.4Pharmaceutical form 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 INNAlendronato sódico
    D.3.9.3Other descriptive nameFosamax
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 No
    D.3.11.3.2Gene therapy medical product No
    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 No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Osteoporosis/Osteopenia Posmenopáusica
    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
    Evaluar el efecto de denosumab en comparación con el del alendronato sódico (ALN) en el cambio porcentual con respecto al nivel basal en la DMO de toda la cadera determinada por DEXA a los 12 meses en mujeres posmenopáusicas
    E.2.2Secondary objectives of the trial
    Evaluar el efecto de denosumab en comparación con ALN en:

    · Cambio porcentual con respecto al nivel basal en la DMO del 1/3 distal del radio, del trocánter de la cadera, del cuello femoral y de las vértebras lumbares a los 12 meses.

    · Seguridad y tolerabilidad determinadas por una evaluación de los acontecimientos adversos, de los parámetros analíticos y de las constantes vitales durante 12 meses.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Mujeres posmenopáusicas ambulatorias según su historial médico

    - Valores de DMO (g/cm2) evaluados en el centro que correspondan a la puntuación T ≤ -2.0 en las vértebras lumbares O en toda la cadera como se indica a continuación:

    GE Lunar Hológico
    Vértebras lumbares ≤ 0.940 ≤ 0.827
    Toda la cadera ≤ 0.756 ≤ 0.698

    - La paciente proporcionará el consentimiento informado por escrito correspondiente antes de que se lleve a cabo ningún procedimiento específico del estudio.
    E.4Principal exclusion criteria
    Cualquier trastorno que no permita a la paciente dar su consentimiento informado escrito y/o cumplir con los procedimientos del estudio.
    Evidencia de cualquiera de lo siguiente:
    a) Hiper- o hipotiroidismo.
    b) Hiper- o hipoparatiroidismo actual
    c) Nivel elevado de transaminasas:
    d) Función renal significativamente reducida, determinada por un nivel de creatinina sérica ≥ 2.0 mg/dL.
    e) Hipo- o hipercalcemia actual basada en los intervalos de referencia del laboratorio.
    f) Úlcera gástrica o duodenal activa; antecedentes de hemorragia gastrointestinal significativa que requiriera hospitalización o trasfusión, o dispepsia o enfermedad de reflujo gastroesofágico que no se pueda controlar con medicación.
    g) Artritis reumatoide, enfermedad de Paget, enfermedad de Cushing, hiperprolactinemia o cirrosis hepática
    h) Paciente con un resultado positivo en la prueba del virus de la inmunodeficiencia humana, virus de la hepatitis C o antígeno de superficie de la hepatitis B.
    i) Proceso maligno (excepto un carcinoma basocelular o escamocelular de la piel, un carcinoma cervical o un carcinoma ductal de mama in situ completamente extirpado) en los últimos 5 años.
    j) Cualquier enfermedad ósea de tipo metabólico, por ejemplo, osteomalacia u osteogénesis imperfecta que pudiera interferir con la interpretación de los resultados.
    k) Síndrome de malabsorción o cualquier trastorno gastrointestinal que esté asociado con la malabsorción.

    - Haber recibido un trasplante de órgano sólido o médula ósea

    - Deficiencia de vitamina D (nivel de 25 (OH) vitamina D < 12 ng/mL).

    - Cualquier anomalía analítica que, en opinión del investigador, no permita que la paciente complete el estudio o interfiera con la interpretación de los resultados del estudio.

    - Paciente que tenga contraindicada o apenas tolere la terapia con ALN.

    - Conocida hipersensibilidad a los productos farmacológicos derivados de las células de mamíferos.

    - Conocida intolerancia a los suplementos de calcio

    - Administración de bifosfonatos intravenosos o flúor (excepto para un tratamiento dental) o ranelato de estroncio.

    - Tratamiento con bifosfonatos orales:

    • ≥ 3 meses acumulados en los últimos 2 años, o
    • ≥ 1 mes en el último año, o
    • Cualquier uso durante los 3 meses previos a la distribución aleatoria

    - PTH o derivados de PTH (por ejemplo, teriparatida) en el último año

    - Administración de cualquiera de los tratamientos siguientes en los 3 meses previos a la distribución aleatoria:

    a) Cualquier SERM (por ejemplo, raloxifeno)
    b) Tibolona
    c) Esteroides anabólicos o testosterona
    d) Glucocorticosteroides (≥ 5 mg de prednisona o equivalente al día durante más de 10 días)
    e) Terapia hormonal sustitutiva sistémica (oral, transdérmica, tópica). Se permitirá una preparación de estrógenos para administración vaginal.
    f) Calcitonina
    g) Calcitrol o derivados de la vitamina D
    h) Otros fármacos activos óseos, incluidos los anti-convulsivos (excepto benzodiacepinas) y heparina
    i) Tratamiento sistémico crónico con ketoconazol, andrógenos, ACTH, cinacalcet, aluminio, litio, inhibidores de la proteasa, metotrexato, agonistas de la hormona liberadora de gonadotropina

    - Altura, peso u obesidad que no permita una medición exacta mediante DEXA

    - Menos de 2 vértebras lumbares (L1-L4) evaluables mediante DEXA

    - Ningún lado de la cadera evaluable mediante DEXA (por ejemplo, antecedentes de reemplazo bilateral de la cadera o clavos en ambos lados de la cadera).

    - Actualmente participando en otro ensayo clínico o que aún no ha transcurrido 1 mes desde la finalización de un ensayo clínico con otro fármaco o dispositivo experimental o que esté recibiendo otros agentes experimentales.

    - Cualquier trastorno físico o psiquiátrico que, en opinión del investigador, no permita a la paciente completar el estudio o interfiera con la interpretación de los resultados del estudio.

    - Evidencia de alcoholismo o drogadicción en los últimos 12 meses que el investigador considere que podría interferir con la comprensión o compleción del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es el cambio porcentual con respecto al nivel basal en la DMO de toda la cadera a los 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 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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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.8.5The 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
    Ultima vista del último 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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 1100
    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 Decision2006-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-12-07
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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