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    Summary
    EudraCT Number:2005-005529-74
    Sponsor's Protocol Code Number:ML19982
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-23
    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 ConcernedLatvia - SAM
    A.2EudraCT number2005-005529-74
    A.3Full title of the trial
    A randomised, open-label, multi-national, multi-center study to investigate the impact of bone-marker feedback (at 3 months) on adherence to once monthly ibandronate treatment of patients with post-menopausal osteoporosis (PMO) supported by PRP (patient relationship program).
    A.3.2Name or abbreviated title of the trial where available
    BOUNCE
    A.4.1Sponsor's protocol code numberML19982
    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 (Hungary) Ltd.
    B.1.3.4CountryHungary
    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.2.5The 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 nameBonviva® 150mg film-coated tablets
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNibandronic acid
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    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
    osteoporosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10031282
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the impact of bone marker feedback (using serum CTX and communication of the results) on adherence to once monthly ibandronate in women with postmenopausal osteoporosis supported by PRP (patient relationship program)
    E.2.2Secondary objectives of the trial
    • To evaluate the satisfaction of treatment with monthly ibandronate for each study arm as well as the whole study population including analyses of different patient categories based on the baseline variables (age, previous osteoporosis treatment if any);
    • To evaluate patient satisfaction with regimen (drug treatment and physician handling);
    • To evaluate patient satisfaction with a method of assessment through biomarker quantification;
    • To evaluate physician satisfaction with a method of assessment through biomarker quantification;
    • To evaluate the effect of monthly ibandronate on suppression of bone turnover markers;
    • To evaluate the impact of adherence to monthly ibandronate on bonemarker response;
    • To assess the safety of monthly ibandronate;
    • To evaluate the impact of PRP on adherence to monthly ibandronate intake
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    • Ambulatory post-menopausal women aged 55-85 years eligible for bisphosphonate treatment, with documented osteoporosis as determined by the treating physician (menopausa is defined by having amenorrhea for at least one year prior to study entry OR by having previous ovariectomy);
    • Patients who are either naive to bisphosphonates or lapsed bisphosphonate users (last bisphosphonate intake>6 months ago);
    • Patients who, in the opinion of the investigator, are able to understand and complete the questionnaires, are willing and able to comply with the protocol requirements;
    • Patients who have signed the informed consent
    E.4Principal exclusion criteria
    • Hypersensitivity to bisphosphonates;
    • Inability to stand or sit in an upright position for at least 60 minutes;
    • Inability to swallow a tablet whole;
    • Contraindications to calcium or vitamin D therapy;
    • Administration of any investigational drug within 30 days preceding the first dose of the study drug;
    • Uncorrected hypocalcemia/hypercalcemia or other disturbances of bone and mineral metabolism;
    • Antiresorptive medication within the last 6 months;
    • Treatment with other drugs affecting bone metabolism;
    • Active disease/ disorder known to influence bone metabolism; eg. liver disease, chronic alcoholism, severe malabsorption syndrome, documented active thyroid disease without treatment;
    • Renal impairment (creatinine clearance <30 mL/min).
    • History of major upper GI disease defined by:
    • Significant upper GI bleeding within the last year requiring hospitalization or transfusion;
    • Recurrent peptic ulcer disease documented by radiographic or endoscopic means;
    • Dyspepsia or gastroesophageal reflux that is uncontrolled by medication;
    • Abnormalities of the esophagus that delay esophageal emptying, such as stricture, achalasia or dysmotility;
    • Active gastric/duodenal ulcers;
    • Patients are not excluded because of previous or active gastrointestinal disease, except as outlined above (eg. symptoms of dyspepsia controlled by daily medication or prior history of non-recurrent peptic ulcer disease are not considered exclusionary)
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of Adherence
    For the primary end point patients are defined as having more than 83% adherence to treatment if they took 5 of the 6 monthly ibandronate tablets within the -1 to +21 days of their osteoporosis treatment date each month. Patient adherence will be assessed by maintaining records of “drug dispensed” and “drug returned” on the CRF and patient self-report at visit 2 and final visit. A drug dispensing log will be maintained by the investigator. Patients will be instructed at the baseline visit and at visit 2 to save and return unused or partially used medication packages on visit 2 and final study visit respectively.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    adherence
    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 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 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.8.5The trial involves multiple Member States Yes
    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
    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
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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) 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 No
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    post-menopausal
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 356
    F.4.2.2In the whole clinical trial 626
    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 Decision2006-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-22
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