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    Clinical Trial Results:
    Effects of Zoledronic Acid on arterial calcification and arterial stiffness in women – a co-twin randomised double blind, placebo-controlled parallel group, clinical trial

    Summary
    EudraCT number
    2010-019656-41
    Trial protocol
    GB  
    Global end of trial date
    21 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    17 Oct 2019
    First version publication date
    17 Oct 2019
    Other versions
    Summary report(s)
    Cancelled Before Active Statement

    Trial information

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    Trial identification
    Sponsor protocol code
    ZA/CP/0210
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College London
    Sponsor organisation address
    The Strand, London, United Kingdom, WC2R 2LS
    Public contact
    Professor P J Chowienczyk, King's College London, 0044 02071884642, phil.chowienczyk@kcl.ac.uk
    Scientific contact
    Professor P J Chowienczyk, King's College London, 0044 02071884642, phil.chowienczyk@kcl.ac.uk
    Sponsor organisation name
    Guy's & St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr P J Chowienczyk, Guy's and St Thomas' NHS Foundation Trust, 0044 02071884642, phil.chowienczyk@kcl.ac.uk
    Scientific contact
    Dr P J Chowienczyk, Guy's and St Thomas' NHS Foundation Trust, 0044 02071884642, phil.chowienczyk@kcl.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Does Zoledronic Acid 5 mg once yearly compared to placebo reduces arterial stiffness?
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial

    Pre-assignment
    Screening details
    N.A

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Z ACID
    Arm description
    Zoledronic acid 5 mg solution for infusion
    Arm type
    Experimental

    Investigational medicinal product name
    Zoledronic Acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dosage would have been Zoledronic Acid 5 mg solution for infusion

    Number of subjects in period 1
    Z ACID
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    -

    Reporting group values
    Overall Trial Total
    Number of subjects
    99999 99999
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    0 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    99999 99999
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Z ACID
    Reporting group description
    Zoledronic acid 5 mg solution for infusion

    Primary: Number of subjects with Adverse Events (AEs): Part 1 [1]

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    End point title
    Number of subjects with Adverse Events (AEs): Part 1 [1] [1]
    End point description
    99999 is "Not applicable" value or 0 participants, this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    N/A
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No subjects were enrolled in the trial hence results are not available
    End point values
    Z ACID
    Number of subjects analysed
    99999 [2]
    Units: 1
        number (not applicable)
    99999
    Notes
    [2] - [1] - No statistical analyses have been specified for this primary end point. It is expected there i
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All adverse events occurring during the course of the clinical trial were to be collected.
    Adverse event reporting additional description
    N/A
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Z ACID
    Reporting group description
    Zoledronic acid 5 mg solution for infusion

    Serious adverse events
    Z ACID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Z ACID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects were enrolled in the trial hence results are not available

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No subjects were enrolled in the trial hence results are not available
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