Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-000184-40
    Sponsor's Protocol Code Number:20130173
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-15
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000184-40
    A.3Full title of the trial
    Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta
    Studio multicentrico, prospettico, a singolo braccio volto a valutare l¿efficacia, la sicurezza e
    la farmacocinetica di denosumab in bambini con osteogenesi imperfetta
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta
    Studio per valutare l'efficacia, la sicurezza e la farmacocinetica di denosumab in bambini con osteogenesi imperfetta
    A.3.2Name or abbreviated title of the trial where available
    Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in
    Studio multicentrico, prospettico, a singolo braccio volto a valutare l¿efficacia, la sicurezza e la
    A.4.1Sponsor's protocol code number20130173
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/058/2016
    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 S.r.l.
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressVia Tazzoli 6
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20154
    B.5.3.4CountryItaly
    B.5.4Telephone number0039026241121
    B.5.5Fax number0039026241121
    B.5.6E-mailmedicalinformationitaly@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 XGEVA - 120 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - FLACONCINO (VETRO) - 1.7 ML 4 FLACONCINI
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNDENOSUMAB
    D.3.9.1CAS number 615258-40-7
    D.3.9.2Current sponsor codeAMG 162
    D.3.9.3Other descriptive nameDenosumab - Immunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m3 milligram(s)/cubic meter
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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
    OSTEOGENESIS IMPERFECTA
    OSTEOGENESI IMPERFETTA
    E.1.1.1Medical condition in easily understood language
    Osteogenesis Imperfecta
    Osteogenesi Imperfetta
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031243
    E.1.2Term Osteogenesis imperfecta
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of denosumab on lumbar spine bone mineral density (BMD) Z-score at 12 months, as assessed by dual-energy X-ray absorptiometry (DXA), in children 2 to 17 years of age (at the time of screening) on a 3-Month Dosing Regimen with OI.
    Valutare l¿effetto di denosumab sullo Z-score di BMD (densit¿ minerale ossea) a livello della colonna lombare a 12 mesi, valutato in base all¿assorbimetria a raggi X a doppia energia (DXA), in bambini di et¿ compresa tra i 2 e i 17 anni con OI (al momento dello screening) su un regime posologico di tre mesi.
    E.2.2Secondary objectives of the trial
    To evaluate denosumab in children 2 to 17 years of age with OI on a 3-Month Dosing Regimen with respect to:
    - Change in lumbar spine BMD Z-score, at 6
    - Change in proximal femur BMD Z-score at 6 and 12 months
    - Incidence x-ray confirmed long bone and new and worsening vertebral fractures from pre-treatment to post-treatment at 12
    - Incidence of improving vertebral fractures from pre-treatment to post treatment at 12 months
    - Incidence of pre-treatment compared with post-treatment vertebral and nonvertebral fractures at 12 months

    *Please, refers to the protocol for the full list
    Valutare l’effetto di denosumab su bambini di età compresa tra i 2 e i 17 anni con OI su un regime posologico di tre mesi in termini di:
    - Variazione dello Z-score di BMD a livello della colonna lombare a 6 mesi
    - Variazione dello Z-score di BMD a livello del femore prossimalea 6 e 12 mesi
    - Incidenza di fratture nuove e peggioramento a livello vertebrae e delle ossa lunghe confermate dall’esame radiografico dal pretrattamentoal post-trattamento a 12 mesi
    - Incidenza di fratture vertebrali in fase di miglioramento dal pre-trattamento al post trattamento a 12 mesi
    - Incidenza di fratture vertebrali e non vertebrali nel pre-trattamento e nel post-trattamento a 12 mesi

    *Fare riferimento al protocollo per la lista completa
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: PK/bone turnover markers (BTM) substudy of approximately 50 subjects to - determine serum concentration of denosumab at 1 and 10 days and 6, 12, 18, 24, 30, and 36 months in all subjects
    - evaluate changes observed in bone turnover markers (bone-specific alkaline phosphatase [BSAP], serum type I collagen C-telopeptide [sCTX])


    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio di PK/bone turnover markers (BTM) in circa 50 soggetti per determinare la concentrazione serica di denosumab al giorno 1 e 10 e ai mesi 6, 12, 18, 24, 30, e 36
    - valutare le modifiche del bone turnover markers (bone-specific alkaline phosphatase [BSAP], serum type I collagen C-telopeptide [sCTX])
    E.3Principal inclusion criteria
    Informed consent (to be provided by parent or legal guardian) andinformed assent (to be provided by subjects when age-appropriate).
    - Children aged 2 to 17 years inclusive at screening
    - Clinical diagnosis of OI defined as a clinical history consistent with type I-IV OI as determined by presence of expected phenotype (examples
    include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional
    features unrelated to type I-IV OI (eg, blindness, mental retardation, neuropathy, craniosynostosis; premature exfoliation of deciduous teeth)
    ¿* If familial, also must be autosomal dominant
    - Clinical severity of OI as defined by
    o 2 or more prevalent vertebral compression fractures; OR
    o 1 prevalent vertebral compression fracture and 1 or more nonvertebral
    fractures within the previous 2 years; OR
    o 3 or more fractures within the previous 2 years
    Consenso informato (fornito dal genitore o dal rappresentante legale) e modulo di assenso del paziente (fornito dai soggetti, se di età adeguata).
    • I bambini di età compresa tra i 2 e i 17 anni compiuti al momento dello screening
    • Diagnosi clinica di OI definita come anamnesi clinica coerente con OI di tipo I-IV
    determinata dalla presenza di fenotipo atteso (gli esempi includono:
    conformazione facciale, voce, sclere blu, dentinogenesi imperfetta, caratteristiche
    radiografiche tipiche, modello delle fratture) e dalla mancanza di ulteriori
    caratteristiche non correlate a OI di tipo I-IV (ad es. cecità, ritardo mentale,
    neuropatia, craniosinostosi, esfoliazione prematura dei denti decidui)
    ¿ Se di carattere familiare, deve essere anche a trasmissione autosomica dominante
    • Gravità clinica di OI definita da o 2 o più fratture vertebrali prevalenti da compressione; O
    1 frattura vertebrale prevalente da compressione e 1 o più fratture non vertebrali nei 2 anni precedenti; O
    3 o più fratture nei 2 anni precedenti
    E.4Principal exclusion criteria
    - Inability or unwillingness to comply with the requirements for frequent calcium and phosphorus monitoring for 14 days after the first dose of denosumab (only applies to the first 5 subjects age 11 to17 enrolled in the study and the first 5 subjects of any age meeting the criteria for increased bone turnover (see Section 2.3.2.1)
    - Currently unhealed fracture or osteotomy as defined by orthopedic opinion
    - Osteotomy within 5 months of screening
    - Evidence of untreated oral cavities or oral infections
    - Recent or planned invasive dental procedure
    - Surgical tooth extraction which has not healed by screening
    - History of an electrophoresis pattern inconsistent with type I to IV OI
    - History of know mutation in a gene other that COL1A1/A2 causing OI or metabolic bone disease
    - Abnormalities of the following per central aboratory reference ranges at screening:
    o Serum albumin corrected calcium < lower limit of normal (LLN)
    o Serum vitamin D < 20 ng/mL; re-screening for Vitamin D level < 20ng/mL will be allowed, after adequate supplementation o Aspartate aminotransferase (AST), alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN) o Total bilirubin (TBL) > 1.5 x ULN (subjects with Gilbert syndrome are eligible)
    o Serum phosphorus < LLN
    o Serum alkaline phosphatase > 20% above the ULN or > 20% below the LLN
    - Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (calculated by the Schwartz equation at screening)
    - Evidence of any of the following:
    o Current hyperthyroidism (unless well-controlled on stable antithyroid therapy)
    o Current clinical hypothyroidism (unless well-controlled on stable thyroid replacement therapy)
    o History of hyperparathyroidism o Current hypoparathyroidism o Current, uncontrolled hypercalcemia (albumin-corrected serum Ca
    >10% ULN) o Current metaphyseal index Z-score > +1 o History of osteomalacia or rickets (chart review)
    o Other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis,
    hypophosphatasia) o History of autoimmune disease
    o History of malabsorption (in children with serum albumin < LLN, malabsorption should be clinically ruled out by the PI to confirm eligibility)
    o History of rare hereditary problems of fructose intolerance o History of long QT syndrome
    o History of non-healing osteotomy o History of malignancy o History of alcohol or drug abuse
    o History of any solid organ or bone marrow transplant o Contraindicated or poorly tolerant of denosumab therapy
    - Positive blood screen for human immunodeficiency virus -1 or -2 antibody
    - Positive blood screen for hepatitis B surface antigen or hepatitis C antibody
    - Currently pregnant or planning a pregnancy during the study and for an additional 5 months after the last dose of denosumab
    - For sexually active girls: refusal to use highly effective methods of contraception and to continue this practice for 5 months after the last injection of denosumab
    • Incapacità o indisponibilità a rispettare i requisiti di monitoraggio frequente di calcio e fosforo per 14 giorni dopo la prima dose di denosumab (si riferisce
    soltanto ai primi 5 soggetti arruolati nello studio di età compresa tra gli 11 e i 17 anni e ai primi 5 soggetti di qualsiasi età che soddisfano i criteri per l’aumento di turnover osseo (si veda la Sezione 2.3.2.1)
    • Frattura corrente od osteotomia non ancora guarite confermate da un ortopedico
    • Osteotomia nei 5 mesi di screening
    • Evidenza di infezioni orali o della cavità orale non trattate
    • Procedura odontoiatrica invasiva recente o programmata
    • Estrazione dentale chirurgica non ancora guarita al momento dello screening
    • Anamnesi di un modello elettroforetico incoerente con OI di tipo I-IV
    • Storia di mutazioni note genetiche oltre alla COL1A1/A2 che causano OI o malattie ossee metaboliche
    • Anomalie dei seguenti intervalli di riferimento secondo il laboratorio centrale al momento dello screening:
    o Concentrazione sierica di calcio corretto per albumina < limite inferiore della norma (LLN)
    o Concentrazione sierica di vitamina D <20 ng/mL; sarà consentito un ulteriore screening per un livello di vitamina D <20 ng/mL dopo un’adeguata supplementazione
    o Aspartato aminotransferasi (AST), alanina aminotransferasi (ALT) >1,5 volte il limite superiore della norma (ULN) o Bilirubina totale (TBL) >1,5 volte l’ULN (i soggetti con sindrome di Gilbert
    sono idonei) o Fosforo sierico < LLN o Fosfatasi alcalina sierica >20% superiore all’ULN o >20% inferiore all’LLN
    • Velocità di filtrazione glomerulare stimata (eGFR) <60 ml/min/1,73 m2 (calcolata mediante equazione di Schwartz al momento dello screening)
    • Evidenza di una delle seguenti condizioni:
    o Ipertiroidismo corrente (ad eccezione dei soggetti sotto controllo in terapia antitiroidea stabile)
    o Ipotiroidismo clinico corrente (ad eccezione dei soggetti sotto controllo in terapia di sostituzione tiroidea stabile) o Anamnesi di iperparatiroidismo o Ipoparatiroidismo corrente o Ipercalcemia corrente non controllata (Ca corretto per albumina >10%ULN) o Z-score dell’indice di metafisi corrente > +1 o Anamnesi di osteomalacia o rachitismo (revisione della cartella clinica) o Altre patologie ossee che influiscono sul metabolismo osseo (ad es.
    sindrome osteoporosi-pseudoglioma, osteoporosi giovanile idiopatica, osteopetrosi, ipofosfatasia)
    o Anamnesi di patologia autoimmune
    o Anamnesi di malassorbimento (in bambini con albumina sierica <LLN, il malassorbimento dovrebbe essere escluso clinicamente dallo sperimentatore per confermare l’eleggibilità) o Anamnesi di rare condizioni ereditarie di intolleranza al fruttosio
    o Anamnesi di sindrome del QT lungo
    o Anamnesi di mancata guarigione dell’osteotomia
    o Anamnesi di neoplasia maligna
    o Anamnesi di abuso di alcol o sostanze stupefacenti
    o Anamnesi di trapianto di organi solidi o midollo osseo
    o Controindicazioni o scarsa tolleranza alla terapia con denosumab
    • Positività agli anticorpi del virus dell’immunodeficienza umana di tipo 1 e 2
    • Positività all’antigene di superficie dell’epatite B o agli anticorpi dell’epatite C
    • Attualmente in gravidanza o pianifica una gravidanza durante lo studio e nei 5
    mesi successivi all’ultima dose di denosumab
    • Per le ragazze sessualmente attive: rifiuto a utilizzare metodi contraccettivi
    altamente efficaci per tutta la durata dello studio e nei 5 mesi successivi all’ultima
    iniezione di denosumab
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in lumbar spine BMD Z-score, as assessed by DXA,
    at 12 months in subjects receiving the 3-Month Dosing Regimen
    Variazione rispetto al basale dello Z-score di BMD a livello della colonna lombare, valutato in base alla DXA, a 12 mesi in soggetti che ricevono il regime posologico di tre mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 months
    a 12 mesi
    E.5.2Secondary end point(s)
    - Change from baseline in lumbar spine BMD Z-score, as assessed by
    DXA, at 6 months in subjects receiving the 3-Month Dosing Regimen
    - Change from baseline in proximal femur BMD Z-score, as assessed by
    DXA, at 6 and 12 months (in subjects 5 years of age and older) in
    subjects receiving the 3-Month Dosing Regimen
    - Incidence of x-ray confirmed long bone and new and worsening vertebral fractures from pretreatment (on 6-Month Dosing Regimen to
    post-treatment on 3-Month Dosing Regimen at 12 months)
    - Subject incidence of improving vertebral fractures from pretreatment on
    6-Month Dosing Regimen to post-treatment on 3-Month Dosing Regimen
    at 12 months
    - Incidence of vertebral and nonvertebral fractures from pretreatment on
    6-Month Dosing Regimen to post-treatment on 3-Month Dosing Regimen at 12 months
    - Change from baseline in CHQ-PF-50 Physical Summary score at 12 months in subjects receiving the 3-Month Dosing Regimen
    - Change from baseline in CHQ-PF-50 Psychological Summary score at
    12 months in subjects receiving the 3-Month Dosing Regimen
    - Change from baseline in CHAQ Disability Index score at 12 months in subjects receiving the 3-Month Dosing Regimen
    - Change from baseline in WBFPRS at 12 months in subjects receiving the
    3-Month Dosing Regimen
    - Change from baseline in growth velocity (determined by calculating
    age-adjusted Z-scores for height, weight and BMI) at 12 months in subjects receiving the 3-Month Dosing Regimen
    - Serum concentration of denosumab and serum bone turnover markers on days 1, 10, 30, 60, and every 3 months in subjects on 3-Month Dosing
    Regimen
    - Serum concentration of denosumab at 1, 10, and 30 days, and 3, 6 and 9 months (PK/BTM substudy; 6-Month Dosing Regimen)
    ¿ Variazione rispetto al basale dello Z-score di BMD a livello della colonna lombare, valutato in base alla DXA, a 6 mesi in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Variazione rispetto al basale dello Z-score di BMD a livello del femore prossimale, valutato in base alla DXA, a 6 e 12 mesi (in soggeti di 5 anni o più) in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Incidenza confermata dall¿esame radiografico per fratture delle ossa lunghe e nuove e pi¿ gravi fratture vertebrali da pre-trattamento (con regime posologico di 6 mesi a post trattamento con regime posologico di 3 mesi a 12 mesi)
    ¿ Incidenza per soggetto di fratture vertebrali in fase di miglioramento da pre-trattamento con regime posologico di 6 mesi a post trattamento con regime posologico di 3 mesi a 12 mesi
    ¿ Incidenza di fratture vertebrali e non vertebrali da pre-trattamento con regime posologico di 6 mesi a post trattamento con regime posologico di 3 mesi a 12 mesi
    ¿ Variazione rispetto al basale del punteggio relativo alla componente fisica del bambino nel CHQ-PF-50 a 12 mesi in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Variazione rispetto al basale del punteggio relativo alla componente psicologica del bambino nel CHQ-PF-50 a 12 mesi in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Variazione rispetto al basale del punteggio relativo all¿indice di disabilit¿ nel CHAQ a 12 mesi in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Variazione rispetto al basale della WBFPRS a 12 mesi in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Variazione rispetto al basale della velocit¿ di crescita (determinata calcolando lo Z-score in base all¿et¿ per altezza, peso e indice di massa corporea [BMI]) a 12 mesi in soggetti che ricevono il regime posologico di 3 mesi
    ¿ Concentrazione sierica di denosumab e marker di turnover osseo sierico ai giorni 1, 10, 30, 60 e ogni 3 mesi in soggetti che ricevono il regime posologico di 3 mesi ai giorni 1 e 10, e a 6, 12, 18, 24, 30 e 36 mesi
    ¿ Concentrazione sierica di denosumab ai giorni 1, 10 e 30 e ai mesi 3, 6 e 9
    (nel sottostudio di farmacocinetica/sui marcatori del turnover osseo; regime posologico di 6 mesi)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See th elist of the secondary end-points
    Si veda l'elenco degli End-point secondari
    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 Yes
    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 No
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Australia
    Canada
    United States
    Bulgaria
    France
    Germany
    Hungary
    Poland
    Spain
    United Kingdom
    Czechia
    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
    the end of the trial is defined as the date when the last subject is last
    assessed for evaluation in the study, which corresponds to the month
    36 visit.
    La fine dello studio ¿ definita come quando l'ultimo soggetto ¿ valutato per ultimo per la valutazione nello studio, che corrisponde alla visita del mese 36.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 Yes
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 80
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 70
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally
    Soggetti minorenni che non possono dare il proprio consenso personale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 94
    F.4.2.2In the whole clinical trial 150
    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)
    According to the current clinical practice
    In accordo alla normale pratica clinica
    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 Decision2015-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA