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    Summary
    EudraCT Number:2007-000226-43
    Sponsor's Protocol Code Number:ML19360
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-03-26
    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 number2007-000226-43
    A.3Full title of the trial
    BONDIR : Bonviva IV dans le traitement des Douleurs liées aux fractures vertébrales ostéoporotiques Récentes.
    Etude multicentrique, randomisée, comparative en double aveugle contrôlée versus placebo évaluant l’efficacité de l’ibandronate intraveineux sur la douleur liée à une fracture vertébrale ostéoporotique récente.
    A.3.2Name or abbreviated title of the trial where available
    BONDIR
    A.4.1Sponsor's protocol code numberML19360
    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 SponsorROCHE
    B.1.3.4CountryFrance
    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 BONVIVA
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited Welwyn
    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.3.2Product code RO 200-5450/V27
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNIbandronic Acid
    D.3.9.2Current sponsor codeRO 200-5450
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3mg/3ml
    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) 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 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
    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
    Patient souffrant d'une fracture vertébrale ostéoporotique récente.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031290
    E.1.2Term Osteoporotic fracture
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10013601
    E.1.2Term Dorsal pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation de l’efficacité de l’ibandronate IV sur la douleur liée à une fracture vertébrale ostéoporotique récente.
    E.2.2Secondary objectives of the trial
    Contrôle de la douleur, mesure de la consommation de soins, durée d’hospitalisation,
    tolérance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Femmes ménopausées ou hommes âgés de plus de 50 ans;
    - Ayant délivré un consentement de participation écrit ;
    - Aptes, selon l'investigateur, à répondre aux questionnaires et à se plier
    aux impératifs de l'étude ;
    - Patients affiliés à un régime de sécurité sociale ou bénéficiaires d’un tel
    régime ;
    - Ayant une fracture vertébrale estimée d’origine ostéoporotique selon
    l’investigateur : confirmée par radiographie de rachis ou imagerie par
    résonance magnétique (IRM) ou tomodensitomètrie (TDM) ;
    - Ayant une fracture vertébrale datant de moins de 4 semaines et dont le
    caractère récent a été confirmé par radiographie de rachis ou imagerie
    par résonance magnétique (IRM) ou tomodensitomètrie (TDM) ou
    scintigraphie ;
    - Souffrant d’une douleur liée à la fracture :
    Atteignant un niveau > 40 mm sur une échelle visuelle analogique (EVA) de 100 mm, lors d’une évaluation en position assise ou à la mobilisation si impossibilité de la position assise, le matin entre 8h et 10h.
    E.4Principal exclusion criteria
    - Femmes non ménopausées et hommes d'âge inférieur ou égal à 50 ans.
    - Patient atteint d’une déficience ne lui permettant pas une bonne
    compréhension des impératifs de l’essai ;
    - Patient ayant déjà été inclus dans le présent essai ;
    - Patient participant ou ayant participé à un essai clinique dans le dernier
    mois
    - Hypocalcémie non-corrigée (calcémie < 2,10 mmol/l) ou Hypercalcémie
    (calcémie > 2,70 mmol/l) ;
    - Insuffisance rénale sévère avec clairance de la créatinine inférieure à
    30 ml/mn ;
    - Prise d’un traitement par bisphosphonate ou parathormone ou teriparatide
    ou ranélate de strontium dans les 3 mois précédant l’inclusion ;
    - Prise concomitante d’un traitement antalgique de palier 3 ;
    - Lombalgie chronique avec douleur de plus de 3 mois nécessitant une
    prise d’antalgiques de plus de 15 jours par mois chaque mois ;
    - Vertébroplastie programmée dans les 7 jours suivant l’inclusion ;
    - Ostéomalacie connue;
    - Maladie de Paget ;
    - Pathologie grave ou évolutive (processus néoplasique/cancer de moins de
    5 ans) à l’exception des carcinomes basocellulaires ;
    - Hypersensibilité aux bisphosphonates ;
    - Hypersensiblité à l’ibandronate (Bonviva®) intraveineux ou à l’un de ses
    excipients ;
    - Hypersensibilté au paracétamol, au dextropropoxyphène et au tramadol
    - Antécédent d’intolérance à l’ibandronate ou à l’un de ses excipients ;
    - Contre-indication au paracétamol(insuffisance hépatocellulaire) ;
    - Contre-indication au dextropropoxyphène (insuffisance rénale sévère) et
    au tramadol (épilepsie non contrôlée par un traitement, prise simultanée
    ou dans les deux semaines précédantes d’IMAO).
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACITE (Critère principal) :
    A J7, pourcentage de succès au traitement par l’ibandronate IV.
    Le succès est défini par l’association des 3 critères suivants :
    1) Diminution ≥ 20% de l’intensité de la douleur à J7 par rapport à la valeur basale (J0), mesurée par une EVA de 100 mm, en position assise ou à la mobilisation si impossibilité de la position assise , le matin entre 8h et 10h.
    2) Avec stabilisation ou diminution de la posologie de l’antalgique concomitant entre J3 et J7.
    3)Sans augmentation du palier de l’antalgique concomitant entre J3 et J7.

    TOLERANCE :
    - Incidence des événements indésirables graves
    - Incidence de tous les événements indésirables
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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.8.3 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 concerned25
    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
    NA
    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 months11
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 state130
    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)
    NA
    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 Decision2007-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-02
    P. End of Trial
    P.End of Trial StatusOngoing
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