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    Summary
    EudraCT Number:2006-005570-42
    Sponsor's Protocol Code Number:FP-008-ES
    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:2007-07-24
    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 number2006-005570-42
    A.3Full title of the trial
    "Ensayo clínico multicéntrico, longitudinal, prospectivo, fase IV que compara dos técnicas de imagen (ImaTx y DXA) para evaluar el efecto anabólico de la PTH (1-84) en mujeres postmenopáusicas con osteoporosis primaria"

    "Multi-centre, longitudinal, prospective, phase IV clinical trial to compare two image technologies (ImaTx and DXA) assessing the anabolic effects of PTH (1-84) in postmenopausal women with primary osteoporosis"
    A.3.2Name or abbreviated title of the trial where available
    STEP
    A.4.1Sponsor's protocol code numberFP-008-ES
    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 SponsorNYCOMED PHARMA S.A.
    B.1.3.4CountrySpain
    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 Yes
    D.2.1.1.1Trade name PREOTACT
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED DANMARK ApS
    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 namePREOTACT
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    D.3.11.13.1Other medicinal product typePARATHYROID HORMONE (rDNA)
    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
    "Prymary postmenopausal osteoporosis"

    "Osteoporosis primaria postmenopáusica"
    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
    "El objetivo primario del estudio es es explorar la relación entre una nueva técnica de diagnóstico (ImaTX), que analiza la estructura trabecular del hueso usando radiografias digitalizadas y la densidad mineral ósea (DMO) medida por densitometría, en mujeres postmenopaúsicas con osteoporosis prmiaria después de ser tratadas con PTH (1-84) "
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ¿Ha otorgado la paciente el consentimiento informado de acuerdo con los requisitos locales antes de llevar a cabo cualquier actividad específica del estudio? Una actividad específica del estudio es cualquier procedimiento que no se hubiera realizado durante el tratamiento habitual de la paciente.
    2. El sujeto ¿es de sexo femenino?
    3. La paciente ¿tiene 65 o más años?
    4. La paciente ¿presenta menopausia (durante más de 5 años) de acuerdo con el criterio del investigador?
    5. ¿Sufre la paciente osteoporosis primaria, con una puntuación T de la columna lumbar < -3,0 DE, determinada por DXA con un máximo de dos fracturas vertebrales lumbares previas?
    6. ¿Tiene la paciente una esperanza de vida superior a 2 años?
    7. ¿Presenta la paciente una indicación clínica para recibir PTH(1-84) y puede recibir dicho tratamiento diariamente (inyectándose por sí misma o recibiendo la inyección de otra persona)?
    E.4Principal exclusion criteria
    1. ¿Ha recibido la paciente tratamiento antirresortivo durante los 6 últimos meses?
    2. ¿Se ha tratado a la paciente con bifosfonatos durante más de 1 año?
    3. ¿Ha recibido la paciente cualquier tratamiento antirresortivo diferente a bifosfonatos, durante más de tres años?
    4. ¿Ha recibido la paciente estroncio, fluoruro o calcitonina durante más de 3 meses en total?
    5. ¿Se ha tratado a la paciente en alguna ocasión con teriparatida o PTH(1-84)?
    6. ¿Está tomando la paciente alguna medicación conocida por afectar el metabolismo del hueso de acuerdo con el criterio del investigador?
    7. ¿Se ha irradiado el esqueleto de la paciente en alguna ocasión?
    8. ¿Se ha tratado en alguna ocasión a la paciente por una osteopatía maligna?
    9. ¿Sufre la paciente alguna enfermedad clínicamente significativa que afecte el metabolismo del calcio, incluyéndose osteopatías metabólicas tales como hiperparatiroidismo, enfermedad de Paget, osteogénesis imperfecta u osteomalacia?
    10. ¿Presenta la paciente antecedentes de hipersensibilidad a la hormona paratiroidea o a cualquiera de los excipientes del fármaco?
    11. ¿Presenta la paciente niveles de calcio sérico elevados (valor total del calcio sérico >10,2 mg/dL) después de al menos 14 días de suplementos con 1000 mg de calcio y 800 UI de vitamina D3?
    12. ¿Sufre la paciente alguna elevación clínicamente significativa de la fosfatasa alcalina sérica de acuerdo con el criterio del investigador?
    13. ¿Sufre la paciente deterioro de la función renal con aclaramiento de creatinina <30 mL/min (determinación indirecta por la creatinina sérica)?
    14. ¿Sufre la paciente deterioro hepático severo definido como puntuación > 9 Child-Pugh?
    15. ¿Ha participado la paciente en un estudio clínico con un medicamento en investigación durante los últimos 30 días?
    16. ¿Presenta la paciente prótesis bilateral de cadera?
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal del estudio es investigar la relación entre una nueva técnica de imagen (ImaTx), que analiza la estructura trabecular del hueso utilizando radiografías digitalizadas, y la densidad mineral ósea (DMO) determinada por absorciometría de rayos X de energía dual (DXA) en la columna lumbar de las mujeres posmenopáusicas (PM) con osteoporosis (OP) tras el tratamiento con PTH (1-84).
    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 No
    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.6.13.1Other scope of the trial description
    Correlación de técnicas de imagen para evaluar respuesta terapéutica
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days
    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 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 state122
    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 Decision2007-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-08
    P. End of Trial
    P.End of Trial StatusOngoing
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