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    Summary
    EudraCT Number:2006-001703-11
    Sponsor's Protocol Code Number:CZOL446HDE31
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-08-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-001703-11
    A.3Full title of the trial
    A multi-center, randomized, open-label, controlled, one-year trial to measure the effect of zoledronic acid and alendronate on bone metabolism in post menopausal women with osteopenia and osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    ROSE
    A.4.1Sponsor's protocol code numberCZOL446HDE31
    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 Pharma GmbH
    B.1.3.4CountryGermany
    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 Aclasta 5 mg Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAclasta 5 mg Infusionslösung
    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 (free of water)
    D.3.9.1CAS number 118072-93-8
    D.3.9.2Current sponsor codeZOL446
    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.IMP: 2
    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 Alendron-Hexal einmal wöchentlich 70 mg
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAlendrom-Hexal einmal wöchentlich 70 mg Tabletten
    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 INNAlendronic acid
    D.3.9.1CAS number 66376-36-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    osteopenia/osteoporosis in postmenopausal women
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    To prove superiority of zoledronic acid compared to alendronate by testing the hypothesis that the change of the level of NTx in serum within the first 12 months after start of therapy in postmenopausal women is higher.
    E.2.2Secondary objectives of the trial
    • To compare the level of NTx and P1NP
    • To compare the level of NTx within subgroups defined by baseline characteristics
    • To compare the effect within subgroups defined by T-score level at entry (-2 to -2.5 (exclusive), -2.5 to -3.0 (exclusive), -3.0 to -3.5 (exclusive), -3.5 to -4.0 (exclusive), -4.0 and lower))
    • To compare the level of compliance and persistence
    • Descriptive analysis of changes in safety lab, AE and vital signs
    • To explore patient preferences for annual i.v. therapy compared to weekly oral therapy
    • To explore the change in quality of life between zoledronic acid and alendronate as measured by VAS and Quallefo-41
    • To explore the number of clinical fractures
    • To explore the change in body height
    • To explore the number of days on osteoporosis related sick leave
    • Descriptive evaluation of onset as well as offset of both treatments at the beginning and at the end of observation period by values of NTx.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. women equal to or older than 55 and up to 90 years (inclusive) at randomization who will be considered post-menopausal according to the following definition:
    a. ≥ 12 months of natural (spontaneous) amenorrhea or
    b. ≥ 12 month post surgical bilateral oophorectomy or
    c. hysterectomized women under 65 years of age with a serum FSH > 20 IU/l and estradiol < 10 pg/ml
    d. hysterectomized women over or equal to 65 years of age
    2. documented T-score of -2.0 or lower; total hip or spine (mean of L1-L4, excluding fractured vertebrae); measured by DXA; measured within a period of 3 month prior to screening
    3. signed informed consent prior to initiation of any study procedure
    E.4Principal exclusion criteria
    1. any woman of child-bearing potential
    2. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)
    3. history of fractures within six month prior to randomization
    4. calculated creatinine clearance below 35 ml/min or urine dipstick 2+ or more for protein (without evidence of contamination or bacteriuria)
    5. serum calcium > 2.75 mmol/l (11.0 mg/dL) or < 2.00 mmol/L (8.0 mg/dL)
    6. serum alkaline phosphatase higher than 2.5 times the upper limit of normal
    7. history of hypersensitivity to the study drugs or to drugs with similar chemical structures
    8. AST or ALT greater than twice the upper limit of normal
    9. history of uveitis, iritis or chronic conjunctivitis
    10. history of retinopathy or nephropathy especially in the presence of uncontrollable IDDM Hb1AC > 10%.
    11. history of abnormalities of the esophagus which may delay esophageal emptying.
    12. not being able to stand or sit upright for 30 minutes
    13. history of invasive malignancy of any organ system, treated or untreated, within the past five years whether or not there is evidence of local recurrence or metastases; excluding basal cell or squamous cell carcinoma of the skin.
    14. treatment with an investigational drug within the past 30 days or 5 half-lives prior to randomization whichever is longer
    15. history of organ transplantation
    16. history of hypoparathyroidism, hyperparathyoidism, osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
    17. any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 12 months
    18. any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial.
    19. previous use of oral and i.v. bisphosphonates, PTH, strontium ranelate, sodium fluoride.
    20. raloxifene, calcitonin,, tibolone or hormone replacement therapy within 6 months prior to randomization.
    21. use of systemic high dose corticosteroids within 6 months prior to screening:
    a. at an average dose of ≥7.5 mg per day of oral prednisone or equivalent for a period of three months or more prior to screening or
    b. at an average dose of 2.5 mg per day of oral prednisone or equivalent for a period of 6 months or more prior to screening
    22. any treatment that affects bone metabolism (e.g. antiepileptics)
    23. bilateral hip and spine surgery, that may interfere with the DXA measurements (e.g. hip replacement)
    24. any kind of tooth extraction during the last 3 months or surgery of the jaw during the last 6 month before inclusion in the study
    25. any kind of jaw bone disease or infection, that may necessitate oral surgery during the course of the study
    26. history of drug or alcohol abuse within the last 2 years
    27. history of non-compliance to medical regimens, or those patients unwilling to comply with the trial protocol.
    28. any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing it
    29. unwillingness or inability to give informed consent
    30. persons directly involved in the execution of this protocol
    31. any disease related litigation
    32. recent history of kidney stones
    33. history of nephrocalcinosis
    34. recent history of vitamin D overdosage
    E.5 End points
    E.5.1Primary end point(s)
    The level of bone activity, as measured by NTx, over the course of 12 months will be assessed using the standardized area under the curve (AUC), which is the primary efficacy variable in this trial.
    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 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 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) 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 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) Yes
    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.8.4.1Number of sites anticipated in Member State concerned58
    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
    LPLV
    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 months6
    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 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 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 state600
    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 Decision2006-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-26
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