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    Summary
    EudraCT Number:2007-005383-27
    Sponsor's Protocol Code Number:CZOL446H2301E2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-19
    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 number2007-005383-27
    A.3Full title of the trial
    A 3-year, multicenter, double-blind, randomized, placebocontrolled extension to CZOL446H2301E1 to evaluate the efficacy and long term safety of 6 and 9 years zoledronic acid treatment of postmenopausal women with osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCZOL446H2301E2
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorNOVARTIS FARMA
    B.1.3.4CountryItaly
    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.3.4Pharmaceutical form 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 INNZoledronic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 infusion
    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
    Post menopausal osteoporosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to demonstrate that the percentage change in BMD of the total hip as measured by DXA at Year 9 relative to Year 6 in patients treated with zoledronic acid for up to 9 years in the CZOL446H2301 core and both extension studies (Group Z9) is significantly greater than in patients treated with zoledronic acid for 6 years in the CZOL446H2301 core and CZOL446H2301E1 studies followed by up to 3 years of placebo in Study CZOL446H2301E2 (Group Z6P3).
    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives are:evaluating the differences between treatment groups with respect to the percentage change in total hip and femoral neck BMD at Year 7,8,and 9 relative to Year 0 for the Z9 group relative to the Z6P3 group;percent change in the total hip BMD at Year 7 and 8 relative to Year 6;the percentage change in femoral neck BMD at Year 7, 8 and 9 relative to Year 6;relative changes in biochemical markers at Year 7,8 and 9 compared to Year 0 for the Z9 group relative to the Z6P3 group;the change in height at Year 9 relative to Year 6 for the Z9 group relative to the Z6P3 group;cumulative incidence of clinical fractures and vertebral fractures at Year 7, 8 and 9 starting from Year 6 for the Z9 group relative to the Z6P3 group. Secondary safety objectives are: evaluating the adverse event profile, cardiac questionnaire, changes in laboratory, renal and ECG parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Women who completed Study CZOL446H2301E1 and have received at least the received at least the 4th and 6th doses of zoledronic acid in Study CZOL446H2301E1 according to the guidelines and instructions provided. 2. Signed written informed consent to participate in the Study CZOL446H2301E2 3. Patients must be considered ambulatory. Patients can be included who are ambulatory with an assistive device (cane, walker, etc). 4. Patients must have been taking the dosage of calcium and vitamin D required in Study CZOL446H2301E1 (1000 to 1500 mg of elemental calcium and 400 to 1200 IU of vitamin D daily) for at least 3 months prior to entry into the CZOL446H2301E2. 5. Patients must have DXA measurements of the hip performed at Visit 11 (CZOL446H2301E1 final study visit).
    E.4Principal exclusion criteria
    1. Patients who demonstrated a major protocol violation in Study CZOL446H2301E1 or patients for whom the investigator feels participation in Study CZOL446H2301E2 is not appropriate. 2. Any prior use of i.v. bisphosphonate other than the study drug during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2. 3. Any use of oral bisphosphonates for more than 1 month total during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2. 4. Any prior use of PTH for more than 1 month during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1but prior to randomization in Study CZOL446H2301E2. 5. Use of systemic corticosteroids (oral or i.v.) at an average dose of greater than or equal to 7.5 mg per day of oral prednisone or equivalent for a period of three months just prior to randomization into Study CZOL446H2301E2. Note: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articularly) are NOT exclusionary. 6. Any use of anabolic steroids or growth hormone for more than 3 months just prior to randomization into Study CZOL446H2301E2. 7. Any prior use of strontium (all formulations). 8. Any use of sodium fluoride for osteoporosis during Study CZOL446H2301E1 and during the period after completion of Study CZOL446H2301E1 but prior to randomization in Study CZOL446H2301E2. 9. Serum calcium less than 8 mg/dL (2.0 mmol/L) at Visit 11 in Study CZOL446H2301E1 or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2. 10. Serum calcium greater than 11.0 mg/dL (2.75 mmol/L) at Visit 11 in Study CZOL446H2301E1 or at a subsequent pre-dose laboratory test prior to randomization in Study CZOL446H2301E2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to demonstrate that the percentage change in total hip BMD as measured by DXA at Year 9 relative to Year 6 in patients treated with zoledronic acid for up to 9 years in the CZOL446H2301 core and both extension studies (Group Z9) is significantly greater than in patients treated with zoledronic acid for 6 years in the CZOL446H2301 core and CZOL446H2301E1 studies followed by up to 3 years of placebo in Study CZOL446H2301E2 (Group Z6P3).
    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 No
    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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    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 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
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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) 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) No
    F.1.1.6Adolescents (12-17 years) No
    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 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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 229
    F.4.2.2In the whole clinical trial 500
    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 Decision2008-12-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-11
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