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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2006-000608-18
    Sponsor's Protocol Code Number:ML20243
    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:2006-04-04
    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 number2006-000608-18
    A.3Full title of the trial
    Estudio abierto y aleatorizado, comparativo de la tolerabilidad renal de Bondronat® 6 mg I.V. en perfusión de 15 minutos frente a 60 minutos en pacientes con metástasis óseas
    A.3.2Name or abbreviated title of the trial where available
    Estudio BON15
    A.4.1Sponsor's protocol code numberML20243
    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 Farma, 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 Information not present in EudraCT
    D.2.1.1.1Trade name Bondronat 6 mg/6 ml concentrado para solución para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameBondronat 6 mg/6 ml concentrado para solución para perfusión
    D.3.2Product code Ro 200-5450
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNÁcido ibandrónico
    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 number6mg/ 6ml
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevención de las complicaciones óseas en pacientes oncológicos que presentan metástasis óseas
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10049038
    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 principal de este estudio es demostrar la equivalencia entre Bondronat® 6 mg perfundido en 15 minutos y Bondronat® 6 mg perfundido en 60 minutos en cuanto a la tolerabilidad renal.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios del ensayo consisten en comparar entre los dos grupos:
    — La tolerabilidad
    — La intensidad del dolor óseo
    — El consumo de analgésicos
    — Las complicaciones óseas
    — El índice del estado funcional de ECOG
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Pacientes mayores de 18 años de edad
    2. Pacientes que presenten neoplasias confirmadas citológica o histológicamente (los pacientes con cáncer de próstata deben haber manifestado progresión de su enfermedad a pesar de haber recibido como mínimo tres meses de terapia hormonal, entendiendo como progresión un incremento del PSA medido en tres ocasiones distintas con el menos dos semanas de diferencia o clara evidencia de nuevas metástasis óseas)
    3. Pacientes con al menos una metástasis ósea (osteoblástica, osteoclástica o mixta) documentada por gammagrafía, radiografía, TAC o RM.
    4. Pacientes que hayan firmado libremente su consentimiento informado por escrito
    5. Pacientes capaces de cumplir con los procedimientos del estudio
    6. En el caso de los pacientes mujeres en edad fértil:
    - prueba de embarzo (ß-HCG) negativa
    - método anticonceptivo eficaz
    7. Índice del estado funcional de ECOG ≤2
    8. Esperanza de vida ≥ 6 meses
    9. Aclaramiento de creatinina (calculado según la fórmula de Cockcroft y Gault) ≥ 30 ml/min
    E.4Principal exclusion criteria
    1. Pacientes mujeres que estén embarazadas o en periodo de lactancia
    2. Paciente con algún problema dentario en curso, en especial infección dentaria o maxilar; traumatismo o intervención quirúrgica dentaria o maxilar en las 6 semanas previas; antecedentes de osteonecrosis maxilar o de retraso de la cicatrización tras una intervención dentaria
    3. Metástasis cerebrales no controladas
    4. Infección severa o concomitante (neumonía, septicemia, pielonefritis, etc.)
    5. Antecedente conocido de enfermedad sistémica con afectación renal (lupus, enfermedad de Wegener, amiloidosis, etc.)
    6. Insuficiencia renal rápidamente progresiva en la inclusión
    7. Trastorno cardiaco no controlado (hipertensión arterial, arritmia, insuficiencia cardiaca congestiva, angina pectoris, etc.)
    8. Hipercalcemia (> 2,7 mmol/L), hipocalcemia (< 2 mmol/L)
    9. Pacientes en tratamiento concomitante con quimioterapia nefrotóxica (metotrexato a dosis > 50 mg/m² o cisplatino) o que la hayan recibido en las 6 semanas previas a la randomización.
    10. Pacientes elegibles para trasplante de células germinales hematopoyéticas en el momento de la inclusión
    11. Pacientes que hayan recibido un bifosfonato en las tres semanas previas a la aleatorización
    12. Hipersensibilidad conocida al ibandronato o a otro bifosfonato
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal del ensayo será la tolerabilidad renal, definida por el aclaramiento de creatinina (calculado según la fórmula de Cockcroft y Gault) 28 días después del fin del tratamiento.
    Variables secundarias:
    • Tolerabilidad (acontecimientos adversos, acontecimientos adversos graves) hasta los 6 meses
    • Tolerabilidad renal (creatinina sérica, valor inverso de la creatinina sérica, aclaramiento calculado) cada 3 semanas hasta los 6 meses
    • Eficacia sobre el dolor óseo, evaluada mediante una EAV (véase el Apéndice 5) cada 3 semanas durante 6 meses
    • Consumo de analgésicos según los 3 peldaños de la OMS
    • Presentación de complicaciones óseas, evaluadas clínicamente o mediante los métodos de diagnóstico por imagen que el investigador considere adecuados (gammagrafía, radiografía, TAC, RM): fracturas vertebrales y no vertebrales, necesidad de radioterapia o de cirugía ósea, aparición de una nueva metástasis ósea
    • Índice del estado funcional de ECOG, evaluado cada 3 semanas durante 6 meses
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Ácido ibandrónico (Bondronat®) 6 mg en 60 minutos
    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.8.5The 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 Information not present in EudraCT
    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
    El final del tratamiento esta definido como la fecha de la última visita del último paciente, sin embargo, las excepciones deben justificarse.
    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 months7
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state206
    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 Decision2006-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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