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    Summary
    EudraCT Number:2012-001821-28
    Sponsor's Protocol Code Number:20110153
    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:2012-10-02
    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 number2012-001821-28
    A.3Full title of the trial
    A Randomized Double-blind Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
    Estudio Aleatorizado Doble ciego para Evaluar la Seguridad y Eficacia de Denosumab Comparado con Ácido Zoledrónico en Mujeres Posmenopáusicas con Osteoporosis Previamente Tratadas con Bifosfonatos Orales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Previously Treated With Oral Bisphosphonates
    Estudio para Evaluar la Seguridad y Eficacia de Denosumab Comparado con Ácido Zoledrónico en Mujeres Posmenopáusicas con Osteoporosis Previamente Tratadas con Bifosfonatos Orales
    A.4.1Sponsor's protocol code number20110153
    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.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 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/infusion 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.3.8INN - Proposed INN615258-40-7
    D.3.9.1CAS number 615258-40-7
    D.3.9.3Other descriptive nameDENOSUMAB
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    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 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 Yes
    D.2.1.1.1Trade name Zometa
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameZoledronic acid
    D.3.2Product code MO5BA08
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZOLEDRONIC ACID
    D.3.9.1CAS number 118072-93-8
    D.3.9.4EV Substance CodeSUB00176MIG
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion in pre-filled syringe
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post Menospausal 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 15.0
    E.1.2Level PT
    E.1.2Classification code 10031282
    E.1.2Term Osteoporosis
    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
    The primary objective of this study is to evaluate if the effect of administering denosumab (60 mg subcutaneously [SC] every 6 months [Q6M]) is not inferior to that of zoledronic acid (5 mg
    intravenously [IV] once yearly) in postmenopausal women with osteoporosis previously treated with oral bisphosphonates with respect to change in bone mineral density (BMD) by dual energy
    x-ray absorptiometry (DXA) of lumbar spine at 12 months.
    El objetivo principal de este estudio es evaluar si el efecto de administrar denosumab (60 mg por vía subcutánea [SC] cada 6 meses [Q6M]) no es inferior al del ácido zoledrónico (5 mg por vía intravenosa [IV] una vez al año) en mujeres posmenopáusicas con osteoporosis previamente tratadas con bisfosfonatos orales con respecto al cambio en la densidad mineral ósea (DMO) determinada por absorciometría por rayos X de energía dual (DXA) en la columna lumbar a los 12 meses.
    E.2.2Secondary objectives of the trial
    Compare the efficacy of administering denosumab (60 mg SC Q6M), with that of zoledronic acid
    (5 mg IV once yearly), on the following:
    - BMD by DXA of total hip at 12 months (non - inferiority)
    - BMD by DXA of lumbar spine at 12 months (superiority)
    - BMD by DXA of total hip at 12 months (superiority)
    Comparar la eficacia de administrar denosumab (60 mg SC Q6M) con la del ácido zoledrónico (5 mg IV una vez al año) en relación con lo siguiente:
    - DMO determinada por DXA de la cadera total a los 12 meses (no inferioridad)
    - DMO determinada por DXA de la columna lumbar a los 12 meses (superioridad)
    - DMO determinada por DXA de la cadera total a los 12 meses (superioridad)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    BTM/PTH sub-study.
    Exploratory Objectives: Compare the effect of administering denosumab (60 mg SC Q6M), with that of zoledronic acid (5 mg IV once yearly), on the following:
    - BMD by DXA of femoral neck and distal radius at month 12
    - serum CTX, P1NP and albumin-adjusted calcium at day 10, months 1, 3, 6, month 6 + 10 days and months 7, 9 and 12
    - serum iPTH at months 1, 3, 6, 7, 9 and 12
    Sub-estudio BTM/PTH .
    Objetivos exploratorios: Comparar el efecto de administrar denosumab (60 mg SC Q6M) con el del ácido zoledrónico (5 mg IV una vez al año) en relación con lo siguiente:
    - DMO determinada por DXA del cuello femoral y del radio distal a los 12 meses.
    - CTX, P1NP y calcio corregido por albúmina séricos a los 10 días, a los 1, 3 y 6 meses, a los 6 meses + 10 días y a los 7, 9 y 12 meses.
    - iPTH sérica a los meses 1, 3, 6, 7, 9 y 12.
    E.3Principal inclusion criteria
    - Subject or subject?s legally acceptable representative has provided informed consent prior to any study specific procedure(s)
    - Ambulatory postmenopausal women. Ambulatory is defined as women who are able to walk, not bedridden; postmenopause is defined as no vaginal bleeding or spotting for at least 12 months prior to screening.
    - Age 55 years or older
    - Received oral bisphosphonate therapy for OP for at least 2 years immediately prior to screening visit
    - Screening BMD (g/cm2) values at the lumbar spine, total hip or femoral neck; values of equal to or less than those listed in the protocol. Eligibility will be determined by a local reading of the DXAs at the investigator site. At least 2 lumbar vertebrae and one hip must be evaluable by DXA at the screening visit.
    - Serum CTX value of <= 0.5 ng/mL at the screening visit as determined by central laboratory
    - El sujeto o el representante legal autorizado del sujeto ha dado su consentimiento informado antes de iniciar cualquier procedimiento específico del estudio.
    - Mujeres posmenopáusicas ambulatorias. Las mujeres ambulatorias son las que pueden caminar y no están encamadas y las posmenopáusicas son las que no han tenido hemorragia o sangrado vaginal durante un mínimo de 12 meses antes de la selección.
    - 55 años de edad o más.
    - Haber recibido tratamiento con bisfosfonatos orales para la OP durante un mínimo de 2 años justo antes de la visita de selección.
    - Valores de la DMO (g/cm2) en la columna lumbar, la cadera total o el cuello femoral en el momento de la selección iguales o inferiores a los indicados en el protocolo. La elegibilidad vendrá determinada por la lectura local de las DXA en el centro investigador. Se deben poder evaluar como mínimo 2 vértebras lumbares y una cadera mediante DXA en la visita de selección.
    - Valor de CTX sérico de <= 0,5 ng/mL en la visita de selección determinado por el laboratorio central.
    E.4Principal exclusion criteria
    - Height, weight or girth which may preclude accurate DXA measurements
    - Received other OP treatment or bone active treatment with the following guidelines
    .administration of denosumab or zoledronic acid at any time
    .administration of the following within the last 5 years
    ..IV bisphosphonate other than zoledronic acid
    ..fluoride or strontium at doses approved for OP
    ..PTH or PTH derivatives within the last year
    - Abnormalities of the following per central laboratory reference ranges:
    .vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL), repletion will be allowed and subjects may be re-screened
    .hypercalcemia
    .elevated transaminases >= 2.0 x upper limits of normal (ULN)
    - Administration of any of the following treatment within 3 months of screening:
    .any selective estrogen receptor modulator (estrogen agonist antagonist)
    .tibolone
    .anabolic steroids or testosterone
    .glucocorticosteroids (>= 5 mg prednisone equivalent per day for more than 10 days or a total cumulative dose of >= 50 mg)
    .systemic hormone replacement therapy (HRT) (subjects stable on HRT for more than 3 months prior is permitted)
    .calcitonin
    .other bone active drugs including anti-convulsants (except
    benzodiazepines) and heparin
    .cathepsin K inhibitor
    .anti-sclerostin antibody
    .chronic systemic ketoconazole, androgens, adrenocorticotrophic hormone, cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin- releasing hormone agonists
    - Evidence of history of any of the following:
    .hyperthyroidism (stable on antithyroid therapy is allowed)
    .hypothyroidism (stable on thyroid replacement therapy is allowed)
    .hypo- or hyperparathyroidism
    .hypo- or hypercalcemia based on the central laboratory reference ranges
    .known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen
    .osteomalacia (chart review)
    .osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive dental procedures (eg, tooth extraction, dental implants, oral surgery in the past 6 months), poor oral hygiene, periodontal and/or pre-existing dental disease
    .recent tooth extraction (within 6 months of screening visit)
    .Paget disease of bone (subject report or chart review)
    .other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review)
    - History of any solid organ or bone marrow transplant
    - Malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years
    - Contraindicated or poorly tolerant of denosumab therapy; contraindications include
    .hypocalcemia
    .hypersensitivity to drug or any component of the drug
    - Contraindicated or poorly tolerant of zoledronic acid therapy; contraindications include the following:
    .hypocalcemia
    .subjects with creatinine clearance of <35 mL/min and in those with evidence of acute renal impairment (calculated using Cockcroft Gault equation)
    .hypersensitivity to any component of zoledronic acid solution
    - Known intolerance to calcium or vitamin D supplements
    - For women of child bearing potential: refusal to use 2 highly effective forms of contraception and to continue this practice for 7 months after last injection of study medication
    - Self-reported alcohol or drug abuse within 12 months prior to screening
    - Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s)
    - Other investigational procedures while participating in this study are excluded
    - Known sensitivity to any of the products or components to be administered during dosing or known sensitivity to mammalian cell derived drug products.
    - Has previously entered this study
    - Subject likely to not be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and Investigator?s knowledge.
    For remaining exlusion criteria please refer to Protocol.
    - Altura, peso y circunferencia que puedan impedir mediciones de DXA precisas.
    - Haber recibido tratamiento para la OP o tratamiento activo óseo con las directrices siguientes:
    .Administración de denosumab o ácido zoledrónico en cualquier momento.
    .Administración de los siguientes durante los últimos 5 años:
    ..Bisfosfonato IV distinto del ácido zoledrónico.
    ..Fluoruro o estroncio en dosis aprobadas para la OP.
    ..PTH o derivados de la PTH durante el último año.
    - Las anomalías siguientes según los intervalos de referencia del laboratorio central:
    .Déficit de vitamina D (nivel de 25 [OH] vitamina D < 20 ng/mL), se permitirá la reposición y los sujetos podrán ser reseleccionados.
    .Hipercalcemia.
    .Aumento de las transaminasas >= 2,0 x límite superior de la normalidad (LSN).
    - Administración de cualquiera de los siguientes tratamientos durante los 3 meses previos a la selección:
    .Cualquier modulador selectivo de los receptores estrogénicos (antagonistas y agonistas de los estrógenos).
    .Tibolona.
    Esteroides anabólicos o testosterona.
    .Glucocorticosteroides (equivalente a >= 5 mg de prednisona al día durante más de 10 días o una dosis total acumulada de >= 50 mg).
    .Terapia hormonal sustitutiva (HRT) sistémica (se permite en sujetos estables con HRT durante más de 3 meses con anterioridad).
    .Calcitonina.
    .Otros fármacos activos óseos como anticonvulsivos (excepto las benzodiazepinas) y heparina.
    .Inhibidor de la catepsina K.
    .Anticuerpos anti-esclerostina.
    .Ketoconazol sistémico crónico, andrógenos, hormona adrenocorticotropa, cinacalcet, aluminio, litio, inhibidores de la proteasa, agonistas de la hormona liberadora de gonadotropina.
    - Indicio de cualquiera de los antecedentes siguientes:
    .Hipertiroidismo (se permite si está estable con tratamiento antitiroideo).
    .Hipotiroidismo (se permite si está estable con un tratamiento sustitutivo tiroideo).
    .Hipoparatiroidismo o hiperparatiroidismo.
    .Hipocalcemia o hipercalcemia según los intervalos de referencia del laboratorio central.
    .Prueba positiva conocida del virus de la inmunodeficiencia humana, del virus de la hepatitis C o del antígeno de superficie de la hepatitis B.
    .Osteomalacia (revisión de la historia clínica).
    .Osteonecrosis de los maxilares (ONM) o factores de riesgo de ONM como procedimientos dentales invasivos (p. ej., extracción dental, implantes dentales o cirugía oral en los últimos 6 meses), higiene bucal deficiente, enfermedad periodontal o enfermedad dental preexistente.
    .Extracción dental reciente (durante los 6 meses anteriores a la visita de selección).
    .Enfermedad de Paget del hueso (notificación del sujeto o revisión de la historia clínica).
    .Otras enfermedades óseas que afecten al metabolismo óseo (p. ej., osteopetrosis u osteogénesis imperfecta) (revisión de la historia clínica).
    - Antecedentes de trasplantes de órganos sólidos o de médula ósea.
    - Neoplasia maligna (excepto cáncer de piel no melanomatoso, carcinoma ductal de mama o cervical in situ) en los últimos 5 años.
    - Contraindicaciones o mala tolerancia al tratamiento con denosumab; las contraindicaciones incluyen:
    .Hipocalcemia.
    .Hipersensibilidad al fármaco o a cualquier componente del fármaco.
    - Contraindicaciones o mala tolerancia al tratamiento con ácido zoledrónico; las contraindicaciones incluyen:
    .Hipocalcemia.
    .Sujetos con aclaramiento de creatinina de < 35 mL/min y con signos de insuficiencia renal aguda (calculado utilizando la ecuación de Cockcroft Gault).
    .Hipersensibilidad a cualquier componente de la solución de ácido zoledrónico.
    - Intolerancia conocida a los suplementos de calcio o vitamina D.
    - Para las mujeres en edad fértil: negativa a utilizar 2 métodos anticonceptivos de alta eficacia y a continuar esta práctica durante 7 meses tras la última inyección de la medicación en estudio.
    - Drogadicción o alcoholismo notificado por el sujeto durante los 12 meses anteriores a la selección.
    - Estar recibiendo tratamiento en otro estudio de investigación de un fármaco o dispositivo o haber transcurrido menos de 30 días desde el fin del tratamiento en otro estudio de investigación de un fármaco o dispositivo.
    - Queda excluido cualquier otro procedimiento de investigación mientras se participe en este estudio.
    - Sensibilidad conocida a cualquiera de los productos o componentes que se van a administrar durante el tratamiento o sensibilidad conocida a productos derivados de células de mamíferos.
    - Haber participado anteriormente en este estudio.
    - Según informan el sujeto y el investigador, es posible que el sujeto no esté disponible para completar todas las visitas o procedimientos del estudio requeridos por el protocolo y/o cumplir todos los procedimientos del estudio.
    Resto de criterios de exclusión ver protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    - percent change from baseline in lumbar spine BMD at month 12 (non-inferiority)
    La variable principal es el cambio porcentual desde el nivel basal en la DMO de la columna lumbar a los 12 meses (no inferioridad).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    Mes 12
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    - percent change from baseline in total hip BMD at month 12 (non-inferiority)
    - percent change from baseline in lumbar spine BMD at month 12 (superiority)
    - percent change from baseline in total hip BMD at month 12 (superiority)
    Las variables secundarias son las siguientes:
    - Cambio porcentual desde el nivel basal en la DMO de la cadera total a los 12 meses (no inferioridad).
    - Cambio porcentual desde el nivel basal en la DMO de la columna lumbar a los 12 meses (no inferioridad).
    - Cambio porcentual desde el nivel basal en la DMO de la cadera total a los 12 meses (superioridad).
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    Australia
    Belgium
    Canada
    Denmark
    Germany
    Poland
    Spain
    United States
    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
    LVLS - último sujeto elegible realiza la visita de fin 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 months2
    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 months2
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 440
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 440
    F.4.2.2In the whole clinical trial 620
    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)
    Care after trial end will be per standard treatment for the condition
    Tratamiento estándar para la enfermedad
    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 Decision2012-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-14
    P. End of Trial
    P.End of Trial StatusCompleted
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