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    Summary
    EudraCT Number:2010-019110-24
    Sponsor's Protocol Code Number:CZOL446HDE43T
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-11-04
    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 number2010-019110-24
    A.3Full title of the trial
    A PHASE 2, SINGLE-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF ZOLEDRONATE IN SUBJECTS WITH EROSIVE HAND OSTEOARTHRITIS
    A.3.2Name or abbreviated title of the trial where available
    ZOLEHO
    A.4.1Sponsor's protocol code numberCZOL446HDE43T
    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 SponsorUniversitätsklinikum Erlangen
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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.3.4Pharmaceutical 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.3.9.1CAS 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 mg
    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
    Erosive hand osteoarthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019115
    E.1.2Term Hand osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the 90-day symptomatic efficacy of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, for the treatment of erosive hand osteoarthritis
    E.2.2Secondary objectives of the trial
    • To determine the effect of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, on pain and function in patients with erosive hand osteoarthritis
    • To determine the effect of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, on disease activity in patients with erosive hand osteoarthritis
    • To determine the effect of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, on quality of life in patients with erosive hand osteoarthritis
    • To evaluate the safety and tolerability of a single dose zoledronate (Aclasta ®) 5 mg IV, compared with placebo, in patients with erosive hand osteoarthritis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 1. Must understand and voluntarily sign an informed consent form
    2. Male or female, must be aged ≥ 18 years at time of consent
    3. Must have a diagnosis of erosive hand osteoarthritis according to ACR criteria for at least six months
    4. Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC) and/or proximal and/or distal interphalangeal joints (radiographs must not be older than one year).
    5. Must have active disease at screening with at least two swollen and tender proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints
    6. Must have a value of at least 40 on the VAS in the patient self-assessment of pain at screening
    7. Must have negative serum rheumatoid factor (RF) and cyclic ciytrulinated peptide antibody (CCP)
    8. Must be able to adhere to the study visit schedule and other protocol requirements
    9. Females must be postmenopausal for at least 24 consecutive months or must have undergone a hysterectomy or bilateral oophorectomy
    10. Must meet the following laboratory criteria:
     Haemoglobin ≥ 9 g/dL
     Haematocrit ≥ 27%
     White blood cell (WBC) count ≥ 3,000/μL (≥ 3.0 X 109/L) and ≤ 14,000/μL (≤ 14 X 109/L)
     Neutrophils ≥ 1,500/μL (≥ 1.5 X 109/L)
     Platelets ≥ 100,000/μL (≥ 100 X 109/L)
     Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
     Creatinine clearance ≥ 35 ml/min
     Total billirubin ≤ 2.0 mg/dL
     Aspartate transaminase (AST [serum glutamic oxaloacetic transaminase, SGOT]) and alanine transaminase (ALT [serum glutamate pyruvic transaminase, SGPT]) ≤ 1.5x upper limit of normal (ULN)
    E.4Principal exclusion criteria
    1. 1. History of malignancy within the previous 5 years
    2. History of any clinically significant cardiac, endocrine, pulmonary, neurological, psychiatric, hepatic, renal, haematological, immunologic, or other major disease
    3. Any clinically significant abnormality on 12-lead ECG at screening
    4. History of parathyroid surgery or malabsorption of any kind including previous resection of the small intestine
    5. History of or treatment for aspirin-sensitive bronchial asthma
    6. Planned dental surgery within the following 12 months from Day 1 of the study
    7. Human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection
    8. History of serious infections (e.g. pneumonia, pyelonephritis) in the previous 3 months
    9. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study medication administration, or may interfere with interpretation of results
    10. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
    11. Laboratory finding of hypocalcaemia at screening or current treatment for hypocalcaemia
    12. History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies
    13. History or diagnosis of fibromyalgia
    14. Evidence of gout, pseudogout or haemochromatosis
    15. Evidence of calcium pyrophosphate deposition disease ( CPPD)
    16. Significant injury to the affected joint within six months prior to screening
    17. History of infected joint or joint prosthesis within the previous 5 years
    18. Any anti-inflammatory or immunosuppressive therapy for any condition including, but not limited to glucocorticoids, methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus, and azathioprine within 35 days prior to randomization
    19. Use of aminoglycoside antibiotics, loop diuretics and any other nephrotoxic drugs within 35 days prior to randomization
    20. Use of NSAIDs within seven days prior to screening
    21. Intra-articular injection of corticosteroids three months prior to randomization
    22. Intra-articular injection of hyaluronate within six month prior to randomization
    23. Use of any investigational medication within six months prior to randomization
    24. Use of “nutriceuticals” and alternative medicine products, if not taken in a stable dose for a minimum of three month prior to randomization
    25. Patients not able to take daily calcium and vitamin D supplements
    26. Patients who participated in this study before
    27. Patients who possibly are dependent on the sponsor or investigator
    28. Patients who have not given consent to the sharing of their pseudonymized data according to §§7(2)15, 12 and 3 GCP-V
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects in each treatment group who achieve a 50% improvement in Australian/Canadian hand arthrosis pain scale (AUSCAN) Index at Day 90 compared with baseline.
    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 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) 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Day 90 after single administration of study drug
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 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 state70
    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 Decision2010-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-12-18
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