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    Summary
    EudraCT Number:2011-001456-11
    Sponsor's Protocol Code Number:20070337
    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:2012-03-13
    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 number2011-001456-11
    A.3Full title of the trial
    A Multicenter, International, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis
    Estudio multicéntrico, internacional, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de AMG 785 en el tratamiento de mujeres con osteoporosis posmenopáusica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of AMG785 Treatment in Postmenopausal Women With Osteoporosis
    Estudio para evaluar la eficacia y seguridad de AMG785 en el tratamiento de mujeres con osteoporosis posmenopáusica
    A.4.1Sponsor's protocol code number20070337
    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 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportUCB Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (Europe) GmbH
    B.5.2Functional name of contact pointIHQ-Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.com
    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.3.2Product code AMG785
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 Yes
    D.2.1.1.1Trade name PROLIA
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    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 nameImmunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
    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) 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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal Osteoporosis
    Osteoporosis posmenopáusica
    E.1.1.1Medical condition in easily understood language
    Osteoporosis
    Osteoporosis
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 effect of AMG 785 treatment for 12 months compared with placebo on the subject incidence of new vertebral fracture
    Evaluar el efecto del tratamiento con AMG 785 durante 12 meses en comparación con placebo sobre la incidencia de nuevas fracturas vertebrales en los sujetos.
    E.2.2Secondary objectives of the trial
    12-month double-blind placebo-controlled study period -
    ? Subject incidence of fractures
    ? Percent changes in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck

    For the overall 24-month study period (12-month double-blind placebo-controlled study period followed by the 12-month open-label denosumab follow-up study period) -
    ? Subject incidence of fractures (new vertebral fracture, clinical fracture, nonvertebral fracture, new or worsening vertebral fracture, major nonvertebral fracture, hip fracture, major
    osteoporotic fracture, and multiple new or worsening vertebral fracture)
    ? Percent changes in BMD at the lumbar spine, total hip, and femoral neck
    Período del estudio de 12m a doble ciego y controlado con placebo:La incidencia de fracturas en los sujetos (fractura clínica, fractura no vertebral, fractura vertebral nueva o empeorada, fractura no vertebral importante, fractura de cadera, fractura osteoporótica importante y fractura vertebral múltiple nueva o empeorada).Los cambios porcentuales en la densidad mineral ósea (DMO) de la columna lumbar, la cadera total y el cuello femoral.Período del CT global de 24m (período del estudio de 12m a doble ciego y controlado con placebo seguido del período del estudio de seguimiento de 12m con denosumab abierto):La incidencia de fracturas en los sujetos (fractura vertebral nueva, fractura clínica, fractura no vertebral, fractura vertebral nueva o empeorada, fractura no vertebral importante, fractura de cadera, fractura osteoporótica importante y fractura vertebral múltiple nueva o empeorada.Los cambios porcentuales en la DMO de la columna lumbar, la cadera total y el cuello femoral.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Pharmacokinetics (PK) Sub-study
    - Bone Turnover Marker (BTM) & Biomarker Sub-study
    - Forearm and Total Body Dual-energy X-ray Absorptiometry (DXA) and High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Sub-study
    - Lumbar Spine and Proximal Femur DXA Sub-study
    - Bone Biopsy Sub-study
    - Calcium Sub-study
    - Audiology Sub-study
    - Osteoarthritis Sub-study
    - Pharmacogenetics Sub-study
    - Subestudio de farmacocinética (PK)
    - Subestudio de marcadores de remodelado óseo (BTM) y de biomarcadores
    - Subestudio de absorciometría de rayos X de energía dual (DXA) en el antebrazo y en el cuerpo total y tomografía computarizada cuantitativa periférica de alta resolución (HR-pQCT)
    - Subestudio de DXA en la columna lumbar y el fémur proximal
    - Subestudio de biopsia ósea
    - Subestudio del calcio
    - Subestudio de audiología
    - Subestudio de artrosis
    - Subestudio de farmacogenética
    E.3Principal inclusion criteria
    - Ambulatory postmenopausal women, age >= 60 to <= 90 years at
    randomization
    - BMD T-score <= -2.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans.
    - At least 2 vertebrae in the L1-L4 region and at least one hip are evaluable by DXA, as assessed by the principal investigator, eg, based on lateral spine x-rays
    - Subject has provided informed consent
    - Mujeres posmenopáusicas ambulatorias, de edad >= 60 y <= 90 años en el momento de la aleatorización.
    - Puntuación T de la DMO <= -2,50 en cadera total o el cuello femoral, evaluada por el proveedor central de dispositivos de imagen en el momento de la selección, basándose en exploraciones con DXA.
    - Al menos 2 vértebras de la región L1-L4 y al menos una cadera son evaluables por DXA, según la evaluación del investigador principal, p. ej. basándose en radiografías laterales de la columna vertebral.
    - El sujeto ha dado su consentimiento informado.
    E.4Principal exclusion criteria
    - BMD T-score <= -3.50 at the total hip or femoral neck
    - History of hip fracture
    - Any severe (SQ3) or more than 2 moderate (SQ2) vertebral fractures
    - Use of the following agents affecting bone metabolism:
    Strontium, fluoride (for osteoporosis), odanacatib (MK-0822)
    IV bisphosphonates: dose received within 5 years prior to randomization
    Oral bisphosphonates
    ? More than 3 years of cumulative use
    ? Any dose received within 6 months prior to randomization
    ? More than 1 month of cumulative use between 6 and 12 months prior to randomization
    - Denosumab: dose received within 18 months prior to randomization
    - Teriparatide or any PTH analogs: dose received within 12 months prior to randomization
    - Systemic oral or transdermal estrogen, SERMs, or calcitonin
    - Androgen deprivation or hormonal ablation therapy
    - Tibolone, cinacalcet: dose received within 3 months prior to
    randomization
    - Systemic glucocorticosteroids: ? 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization
    - History of metabolic or bone disease that may interfere with the interpretation of the results
    - History of solid organ or bone marrow transplants
    - History of osteonecrosis of the jaw
    - Vitamin D insufficiency, defined as 25 (OH) vitamin D levels < 20 ng/mL
    - Current hyper- or hypocalcemia
    - Current, uncontrolled hyper- or hypothyroidism
    - Current, uncontrolled hyper- or hypoparathyroidism
    - Possible diagnosis of multiple myeloma or related myeloproliferative disorder
    - Contraindicated or intolerant to denosumab therapy
    - Puntuación T de la DMO <= -3,50 en la cadera total o el cuello femoral.
    - Antecedentes de fractura de cadera.
    - Cualquier fractura vertebral grave (SQ3) o más de 2 fracturas vertebrales moderadas (SQ2)
    - Uso de los agentes siguientes, que afectan al metabolismo óseo:
    Estroncio, flúor (para la osteoporosis), odanacatib (MK-0822): en cualquier momento.
    Bisfosfonatos IV: dosis recibida en los 5 años anteriores a la aleatorización.
    Bisfosfonatos orales:
    ?Más de 3 años de uso acumulado.
    ?Cualquier dosis recibida en los 6 meses anteriores a la aleatorización.
    ?Más de 1 mes de uso acumulado entre los 6 y los 12 meses anteriores a la aleatorización.
    -Denosumab: dosis recibida en los 18 meses anteriores a la aleatorización.
    -Teriparatida o cualquier análogo de la PTH: dosis recibida en los 12 meses anteriores a la aleatorización.
    -Estrógeno sistémico oral o transdérmico, SERM o calcitonina: más de 1 mes de uso acumulado en los 6 meses anteriores a la aleatorización.
    -Supresión androgénica o terapia de supresión hormonal: más de 1 mes de uso acumulado en los 6 meses anteriores a la aleatorización.
    -Tibolona, cinacalcet: dosis recibida en los 3 meses anteriores a la aleatorización.
    -Glucocorticosteroides sistémicos: ? 5 mg de prednisona equivalente por día durante más de 10 días en los 3 meses anteriores a la aleatorización.
    -Antecedentes de enfermedad ósea o metabólica (excepto osteoporosis) que puedan interferir en la interpretación de los resultados.
    -Antecedentes de trasplantes de órganos sólidos o de médula ósea.
    -Antecedentes de osteonecrosis de mandíbula.
    -Déficit de vitamina D, definida como niveles de 25 (OH) vitamina D < 20 ng/mL,
    -Hipo o hipercalcemia
    -Hiper o hipotiroidismo no controlado.
    -Hiper o hipoparatiroidismo no controlado
    -Posible diagnóstico de mieloma múltiple o trastorno mieloproliferativo relacionado.
    -Con contraindicación o intolerancia al tratamiento con denosumab
    E.5 End points
    E.5.1Primary end point(s)
    During the 12-month double-blind placebo-controlled study period
    ? Subject incidence of new vertebral fracture through Month 12
    Durante el período del estudio de 12 meses a doble ciego y controlado con placebo
    ?Incidencia en los sujetos de nuevas fracturas vertebrales hasta el mes 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    E.5.2Secondary end point(s)
    During the 12-month double-blind placebo-controlled study period:
    ? Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) through Month 12
    ? Subject incidence of nonvertebral fracture through Month 12
    ? Subject incidence of new or worsening vertebral fracture through Month 12
    ? Subject incidence of major nonvertebral fracture (pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip) through Month 12
    ? Subject incidence of hip fracture through Month 12
    ? Subject incidence of major osteoporotic fracture (hip, wrist, humerus, and clinical vertebral) through Month 12
    ? Subject incidence of multiple new or worsening vertebral fracture through Month 12
    ? Percent change from baseline in BMD at the lumbar spine, total hip, and femoral neck at Month 12
    Durante el período del estudio de 12 meses a doble ciego y controlado con placebo
    ?Incidencia en los sujetos de fracturas clínicas (fracturas no vertebrales y fracturas vertebrales clínicas) hasta el mes 12.
    ?Incidencia en los sujetos de fracturas no vertebrales hasta el mes 12.
    ?Incidencia en los sujetos de fracturas vertebrales nuevas o empeoradas hasta el mes 12.
    ?Incidencia en los sujetos de fracturas no vertebrales importantes (pelvis, fémur distal, tibia proximal, costillas, húmero proximal, antebrazo y cadera) hasta el mes 12.
    ?Incidencia en los sujetos de fracturas de cadera hasta el mes 12.
    ?Incidencia en los sujetos de fracturas osteoporóticas importantes (cadera, muñeca, húmero y vertebrales clínicas) hasta el mes 12.
    ?Incidencia en los sujetos de fracturas vertebrales múltiples nuevas o empeoradas hasta el mes 12.
    ?Cambio porcentual desde el nivel basal en la DMO de columna lumbar, cadera total y cuello femoral hasta el mes 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    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 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) No
    E.8.2.2Placebo Yes
    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 EEA80
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Czech Republic
    Denmark
    Estonia
    Germany
    Hungary
    India
    Japan
    Latvia
    Lithuania
    Mexico
    New Zealand
    Peru
    Poland
    Romania
    Spain
    Switzerland
    United Kingdom
    United States
    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
    LVLP
    Se define como la fecha en la que el último sujeto finaliza el último procedimiento del estudio.
    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 months0
    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 months0
    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 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5400
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3385
    F.4.2.2In the whole clinical trial 5600
    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)
    Normal treatment of the condition
    Tratamiento habitual de la condición
    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 Decision2012-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-28
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