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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2015-001698-41
    Sponsor's Protocol Code Number:P140909
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-02
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001698-41
    A.3Full title of the trial
    Non-inferiority trial of three cycles of zoledronic acid versus
    percutaneous thermal ablation in osteoid osteoma
    Traitement de l’ostéome ostéoïde : étude de non-infériorité de trois perfusions d’acide zolédronique par rapport à une destruction tumorale percutanée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Non-inferiority trial of three cycles of zoledronic acid versus
    percutaneous thermal ablation in osteoid osteoma
    A.3.2Name or abbreviated title of the trial where available
    BISPHOO
    A.4.1Sponsor's protocol code numberP140909
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Acide zolédronique
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAcide zolédronique
    D.3.2Product code EU/1/01/176/003
    D.3.4Pharmaceutical form Powder and solvent for solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravitreal use
    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 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 Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    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
    les patients ayant un ostéome ostéoïde douloureux, La population étudiée concernera les enfants, les adolescents et les jeunes adultes. L'ostéome ostéoïde est rare avant l'âge de cinq ans et après 40 ans.
    E.1.1.1Medical condition in easily understood language
    we investigate children, adolescents and young adults with an osteoid osteoma, a small benign bone tumor. Osteoid osteoma are unusual before the age of five years and after forty years
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10031249
    E.1.2Term Osteoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that in patients with OO, treatment with three intravenous cycles of 4mg of zoledronic acid (Zoledronic acid) administered monthly, is non-inferior to treatment with percutaneous thermal ablation on the efficacy measured by the percentage of pain relief between baseline and end of treatment.
    Montrer la non-infériorité de trois perfusions d'acide zolédronique en terme d'efficacité par rapport à une intervention de destruction tumorale percutanée pour le traitement d'un ostéome ostéoïde, mesurée par le pourcentage de variation de la douleur
    E.2.2Secondary objectives of the trial
    To demonstrate that in patients with OO, treatment with three intravenous cycles of 4mg of zoledronic acid (Zoledronic acid) administered monthly, is non-inferior to treatment with percutaneous thermal ablation on the efficacy measured by the percentage of pain relief between baseline and end of treatment.
    a) Objectifs secondaires d'efficacité
    - Evaluer la douleur, l'impression de changement, la consommation d'antalgiques et d'AINS.
    - Etudier l'évolution de la minéralisation du nidus.
    - Etudier l'évolution de l'œdème péri lésionnel.
    - Documenter la cinétique de l'efficacité du traitement de l'acide zolédronique.
    b) Objectifs secondaires de sécurité
    - Comparer la tolérance et les effets secondaires des perfusions d'acide zolédronique et de la destruction percutanée.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NA
    E.3Principal inclusion criteria
    - Age superior or equal to 10 years
    - Patient with a typical osteoid osteoma diagnosed on clinical and radiological criteria, validated by a binomial clinician / radiologist Both radiological exams should not be older than 3 months prior to inclusion visit (if not, to be repeated before treatment).
    - OO never treated or recurrent OO.
    - OO percutaneously accessible
    - Pain intensity is superior or equal to 40 mm on a VAS at inclusion visit.
    - Written informed consent signed by the patient or his representative (for minors, agreement of the child and signature of the two mandatory parents).
    - Patient affiliated to the social security.
    - Patient âgé de 10 ans et plus (accord des deux parents nécessaire jusqu’aux 18 ans de l’enfant)
    - Patient ayant un ostéome ostéoïde typique diagnostiqué sur des critères et radiologique, validé par un binôme clinicien/radiologue. Si les examens radiologiques datent de plus de 3 mois lors de l’inclusion, ils devront être refaits avant le traitement.
    - OO jamais traité ou récidive d’un ostéome ostéoïde traité antérieurement
    - OO accessible par voie percutanée
    - Douleur osseuse cotée à 40 ou plus sur une échelle visuelle analogique de 0 à 100 le jour de la visite d’inclusion.
    - Patient étant affilié à un régime de la sécurité sociale ou ayant droit ou CMU.
    - Patient qui accepte de signer un consentement écrit après explication orale. Pour les mineurs signatures des deux parents obligatoires et accord de l’enfant.
    E.4Principal exclusion criteria
    - Patients with other diseases or receiving treatment that may impact on bone tissue or its metabolism.
    - Patients suffering from renal failure (i.e. lower than 60 ml/min according to the Cowcroft equation).
    - Patients with severe hepatic impairment, which may alter the rate of alkaline phosphatase, such as hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hepatic cirrhosis.
    - Patients with a history of iritis or uveitis.
    - Patient with untreated rickets or osteomalacia.
    - Patient with untreated dental infection or planed dental surgery during the study period.
    - Patient with untreated infection of the external auditory canal (ex: furuncle, eczema superinfection)
    - Patient already treated by bisphosphonates.
    - Patients with hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients (List of excipients: mannitol (E421), sodium citrate (E331), water for injections).
    - Pregnant or breastfeeding women, or women of child bearing potential (women following menarche and until post-menopause) planning pregnancy during the course of the study (a highly effective contraceptive measure is required during the period of treatment.)
    - Patient enrolled in another biomedical research protocol and during the whole study
    - Patient ayant d’autres maladies ou recevant des traitements pouvant retentir sur le tissu osseux ou son métabolisme.
    - Patient ayant une insuffisance rénale (définie sur une clairance de la créatinine, calculée par la formule de Cowcroft, inférieure à 60 ml/mn).
    - Patient ayant une insuffisance hépatique sévère, qui pourrait modifier le taux de phosphatases alcalines, telle qu’hépatite, cholangite sclérosante, cirrhose biliaire primitive, cirrhose hépatique.
    - Patient avec infection dentaire non traitée ou une chirurgie dentaire planifiée au cours de la période d'étude.
    - Patient avec une infection non traitée du conduit auditif externe (exemple : furoncle, surinfection d'un eczéma).
    - Patient ayant des antécédents d’iritis ou d’uvéite.
    - Patient ayant un rachitisme ou une ostéomalacie non traité.
    - Patient déjà traité par des bisphosphonates, utilisation antérieure de bisphosphonates ou de fluor.
    - Patient ayant une hypersensibilité connue au principe actif, à d’autres bisphosphonates ou à l’un des excipients (Liste des excipients : mannitol (E421), citrate de sodium (E331), eau pour préparations injectables).
    E.5 End points
    E.5.1Primary end point(s)
    Success of treatment: Success is defined as a percentage of decrease in bone pain measured on a visual analog scale (VAS) between baseline (inclusion visit) and the end of treatment larger or equal to 70%. End of treatment is set at one month after the last administration of bisphosphonates and three months after the percutaneous thermal destruction (ie 4 months after inclusion visit = V4 visit, for both groups).
    Le critère d'évaluation principal est le pourcentage de diminution de la douleur entre la visite d'inclusion (avant début du traitement) et la fin du traitement en visite V4 (4 mois +/- 5 jours après inclusion) ce qui correspond à 3 mois (+/- 5jours) après le geste percutané et 1 mois (+/- 5 jours) après la dernière perfusion de bisphosphonates, c'est à dire à trois mois de la mise en route du traitement dans les deux bras.
    Le traitement par bisphosphonates sera jugé non-inférieur au traitement percutané si le pourcentage de diminution de la douleur osseuse est égal ou supérieur à 70%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    Success of treatment: Success is defined as a percentage of decrease in bone pain measured on a visual analog scale (VAS) between baseline (inclusion visit) and the end of treatment larger or equal to 70%. End of treatment is set at one month after the last administration of bisphosphonates and three months after the percutaneous thermal destruction (ie 4 months after inclusion visit = V4 visit, for both groups).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Pain, assessed by Visual Analog Scale (VAS, annex 2) as an average over the past 48 hours, at V1 (1 month +/- 5 days), V2 (2 months +/- 5 days), V3 (3 months +/- 5 days), V7 visits (16 months +/- 1 month) and, in case of additional infusions, at V5 (7 months +/- 15 days) and V6 (10 months +/- 15 days)
    •Patient'Global Impression of change (PGIC) from V2 to V7 visits (PµGIC, annex 3).
    •Consumption of analgesic and NSAIDs:
    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 No
    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.6.13.1Other scope of the trial description
    na
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Destruction tumorale percutanée
    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 concerned14
    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 years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    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: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    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 Yes
    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 state100
    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 Decision2016-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-28
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