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    Summary
    EudraCT Number:2007-001041-17
    Sponsor's Protocol Code Number:20060289
    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:2007-09-18
    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 number2007-001041-17
    A.3Full title of the trial
    Estudio de extensión abierto y de un solo brazo para evaluar la seguridad a largo plazo y la eficacia continuada de Denosumab (AMG 162) en el tratamiento de la osteoporosis posmenopáusica
    A.4.1Sponsor's protocol code number20060289
    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 Kingdom
    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 No
    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 nameAbx 1-6 CHO OPG Ligand mAb IgG2; Human Monoclonal Antibody to RANKL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 No
    D.3.11.8Extractive medicinal product No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Tratamiento de la osteoporosis posmenopáusica
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Describir la seguridad y tolerabilidad en un máximo de 5 años de administración de denosumab, medidas por el seguimiento de los acontecimientos adversos, la inmunogenia y los parámetros analíticos de seguridad en sujetos que recibían denosumab previamente.
    E.2.2Secondary objectives of the trial
    Describir:
    •efecto de la adm.de AMG162 sobre los cambios en la columna lumbar, DMO de la cadera y del radio distal en sujetos que recibían AMG162 previamente y en sujetos que recibían placebo previamente.
    •incidencia de fract. vertebrales y no vert. tras la adm. de AMG162 en sujetos que recibieron previamente AMG162 y en sujetos que recibieron placebo previamente.
    •efecto de la adm. de AMG162 sobre los marcadores de recambio óseo en sujetos que recibían previamente AMG162 y en sujetos que recibían previamente placebo.
    •cambio en los valores del Ca sérico entre las visitas basal y día 10 en sujetos que recibían previamente AMG162 y en sujetos que recibían previamente placebo.
    •efecto en un máx. de 5 años de adm. de AMG162 sobre la histología ósea en sujetos que recibían previamente AMG162.
    •seguridad y tolerabilidad en un máx.de 2 años de adm. de AMG162
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudio de marcadores de recambio óseo (29 may 2007):
    Se recogerá suero para determinar los marcadores bioquímicos (CTX de tipo 1, iPTH, RANKL, OPG, BALP, P1NP) en un subgrupo de sujetos que participaron en el subestudio de marcadores óseos del 20030216 en las visitas del día 10, del mes 6, del mes 12 y del mes 24 para evaluar el efecto del tratamiento con denosumab sobre el recambio óseo y otros parámetros óseos.

    Subestudio DXA (29 may 2007)
    A los sujetos que participaron en el subestudio de DXA del 20030216 se les pedirá que se sometan a nuevas evaluaciones de densitometría ósea del radio distal en las visitas del mes 12 y del mes 24.

    Subestudio de biopsia ósea transilíaca (29 may 2007):
    Un objetivo de aproximadamente 50 sujetos que recibieron tratamiento con denosumab durante 5 años será elegido para someterse a una biopsia ósea transilíaca en los 56 días previos a la visita final del estudio.
    E.3Principal inclusion criteria
    Los sujetos deben firmar el consentimiento informado antes de realizar ningún procedimiento específico y deben estar de acuerdo en recibir una inyección s.c. de 60 mg de denosumab cada 6 meses.

    Los sujetos no deben haber suspendido el producto en investigación durante el estudio 20030216, y deben haber acudido a la visita del mes 36 del estudio 20030216.
    E.4Principal exclusion criteria
    -Los sujetos hospitalizados permanentemente (está permitida la utilización de un dispositivo de ayuda, como un bastón, un andador, etc.).
    -No han recibido dos o más dosis de producto en investigación durante el estudio 20030216.
    -El sujeto presenta un trastorno de cualquier tipo que, según el criterio del investigador, compromete su capacidad de proporcionar el consentimiento informado escrito y/o cumplir con los procedimientos del estudio.
    -Sensibilidad desarrollada a productos derivados de células de mamíferos durante el estudio 20030216.
    -Incapaz de tolerar los suplementos de calcio durante los últimos 6 meses de participación en el estudio 20030216 (entre las visitas del mes 30 y el mes 36 del estudio 20030216).
    -Está recibiendo cualquier producto en investigación que no sea denosumab.
    -Uso actual de los siguientes agentes para la osteoporosis: Bisfosfonatos, calcitonina, fluoruro, hormona paratiroidea, moduladores selectivos del receptor estrogénico, estrógeno sistémico oral o transdérmico (excepto los preparados vaginales y las cremas estrogénicas, que son aceptables), estroncio o tibolona.
    -Para los sujetos del subestudio de biopsia ósea: Sensibilidad conocida o sospechada o contraindicación a los derivados de la tetraciclina.
    E.5 End points
    E.5.1Primary end point(s)
    Seguimiento de la seguridad, incluyendo la incidencia de acontecimientos adversos, la incidencia de acontecimientos adversos graves, las alteraciones en los analitos hallados en los parámetros analíticos de seguridad (bioquímica sérica, hematología) y la incidencia en el sujeto de la formación de anticuerpos anti-denosumab en sujetos tratados previamente con denosumab que recibieron denosumab durante un período máximo de 5 años.
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA148
    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 Yes
    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
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    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 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 state188
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4395
    F.4.2.2In the whole clinical trial 5600
    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 Decision2007-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-19
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