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    Summary
    EudraCT Number:2014-002118-21
    Sponsor's Protocol Code Number:CPZOL
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-10-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-002118-21
    A.3Full title of the trial
    Zoledronate against fractures in children with cerebral palsy
    Zoledronat mod frakturer hos børn med cerebral parese
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Zoledronate against fractures in children with cerebral palsy
    Zoledronat mod knoglebrud hos børn med spastisk lammelse
    A.4.1Sponsor's protocol code numberCPZOL
    A.5.4Other Identifiers
    Name:Regional health research ethics application numberNumber:1-10-72-204-14
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRanders Regional Hospital
    B.1.3.4CountryDenmark
    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 supportThe Research Foundation of The Central Denmark Region
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRanders Regional Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAarhus University
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportDagmar Marshalls Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRiisfort Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportLinex Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRanders Regional Hospital
    B.5.2Functional name of contact pointResearch Unit
    B.5.3 Address:
    B.5.3.1Street AddressSkovlyvej 15
    B.5.3.2Town/ cityRanders NE
    B.5.3.3Post codeDK-8930
    B.5.3.4CountryDenmark
    B.5.4Telephone number457842 0172
    B.5.6E-mailzol.mod.brud@gmail.com
    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 Zoledronsyre ”Fresenius Kabi”
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi AB, Rapsgatan 7, 751 74 Uppsala, Sverige
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 namezoledronate
    D.3.2Product code zol
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    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 codeZOL
    D.3.9.3Other descriptive nameZoledronate
    D.3.9.4EV Substance CodeSUB00176MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.8
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    cerebral palsy, osteopenia, fracture
    cerebral parese, osteopeni, fraktur
    E.1.1.1Medical condition in easily understood language
    physical impairment, low bone density, broken bone
    spastisk lammelse, lav knogletæthed, knoglebrud
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049088
    E.1.2Term Osteopenia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level HLT
    E.1.2Classification code 10034157
    E.1.2Term Pathological fractures and complications
    E.1.2System Organ Class 100000005035
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049904
    E.1.2Term Osteoporosis prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10021740
    E.1.2Term Infantile cerebral palsy
    E.1.2System Organ Class 100000012650
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006002
    E.1.2Term Bone pain
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013522
    E.1.2Term Disuse osteoporosis
    E.1.2System Organ Class 100000018618
    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 effect of 12 months treatment with i.v. zoledronic acid on bone mineralization in children with non-ambulatory cerebral palsy.
    Undersøge virkningen af 12 måneders behandling med i.v. zoledronsyre på knoglemineraliseringen hos børn med cerebral parese uden gangfunktion.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of 12 months treatment with i.v. zoledronic acid on fractures, pain and quality of life in children with non-ambulatory cerebral palsy.
    Undersøge virkningen af 12 måneders behandling med i.v. zoledronsyre på frakturer, smerter og livskvalitet hos børn med cerebral parese uden gangfunktion.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study title: Bone microstructure and response to zoledronat in children with cerebral palsy.
    Date and version: Jan 9 2017, version 7
    Objective: To evaluate the effect of 12 months treatment with i.v. zoledronic acid on bone microstructure in children with non-ambulatory cerebral palsy.
    Substudie: Effekten af zoledronat på knoglemikrostrukturen hos børn med cerebral parese.
    Dato og version: 9. jan 2017, version 7
    Undersøge virkningen af zoledronsyre på knoglernes mikrostruktur hos børn med cerebral parese uden gangfunktion.
    E.3Principal inclusion criteria
    Child age 5-17 years
    Cerebral palsy GMFCS level 4 or 5
    Bone Mass Density z-score below -1
    Barn 5-17 år
    Cerebral parese GMFCS level 4 eller 5
    Bone Mass Density z-score under -1
    E.4Principal exclusion criteria
    Previous treatment with any disphosphonate
    Inability to receive medication via i.v. route
    Hydroxy-vitamin D level below 50
    Bone metabolic disease
    Liver/kidney disease
    Tidligere behandling med bisfosfonat
    Umuligt at give i.v. medicin
    OH-D-vitamin under 50
    Knoglemetabolisk sygdom
    lever- eller nyresygdom
    E.5 End points
    E.5.1Primary end point(s)
    Bone Mass Density z-score change
    Bone Mass Density z-score ændring
    E.5.1.1Timepoint(s) of evaluation of this end point
    0 days
    1 year
    0 dage
    1 år
    E.5.2Secondary end point(s)
    Pain score change
    Well-being score change
    Fracture occurence
    Smerte score ændring
    Velbefindende score ændring
    Frakturforekomst
    E.5.2.1Timepoint(s) of evaluation of this end point
    0 days
    1 year
    0 dage
    1 år
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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 No
    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
    LVLS
    Sidste besøg af sidste deltager
    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 days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 31
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 21
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    all subjects have motor disability, subjects may be mentally handicapped, subjects may be institutionalised
    alle deltagere har motor handicap, deltagere kan være mentalt handicappede, deltagere kan være institutionaliserede
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    all subjects have osteopenia
    alle deltagere har ostepeni
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    10 year monitoring of fractures
    10 års monitorering af frakturer
    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 Decision2017-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-01
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