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    Clinical Trial Results:
    EFFICACY AND SAFETY ASSESSMENT OF ZOLEDRONATE IN HIV-INFECTED PATIENTS WITH LOW BONE MINERAL DENSITY

    Summary
    EudraCT number
    2008-005051-18
    Trial protocol
    ES  
    Global end of trial date
    10 Nov 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Mar 2019
    First version publication date
    29 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VIH-ZOL
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00795483
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Fundació Lluita contra la SIDA
    Sponsor organisation address
    Crta de Canyet s/n, Badalona, Spain, 08916
    Public contact
    Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA, 34 93 497 84 14,
    Scientific contact
    Fundació Lluita contra la SIDA, Fundació Lluita contra la SIDA, 34 93 497 84 14,
    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
    30 Apr 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Nov 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and tolerability of two doses of zoledronate, by comparing three groups of patients: those with annual administration, those with biennial administration (one dose in 2 years) and a control group with no administration of zoledronate.
    Protection of trial subjects
    not specific
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Dec 2008
    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
    Spain: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    We invited patients with chronic HIV-1 infection and low bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) in lumbar spine or hip to participate in the study.

    Pre-assignment
    Screening details
    At week 48, patients from the zoledronate group were randomized again (1:1) to receive a second dose of zoledronate (5 mg) 1 year after the first dose (two doses in 2 years) or to continue with diet counselling only (no second dose of zoledronate). Patients in the control group continued to receive diet counselling only until week 96.

    Period 1
    Period 1 title
    overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Control group
    Arm description
    diet counselling (to assure appropriate vitamin D and calcium intake (1200–1500 mg of calcium and 800 mg of vitamin D per day)
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    One year zoledronate group
    Arm description
    zoledronate (intravenous infusion; 5 mg/year) combined with diet counselling
    Arm type
    Experimental

    Investigational medicinal product name
    Zoledronate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/year (single dose)

    Arm title
    Two-year zoledronate group
    Arm description
    zoledronate (intravenous infusion; 5 mg/year during two years) combined with diet counselling
    Arm type
    Experimental

    Investigational medicinal product name
    Zoledronate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    5 mg/year

    Number of subjects in period 1
    Control group One year zoledronate group Two-year zoledronate group
    Started
    10
    9
    12
    Completed
    8
    9
    12
    Not completed
    2
    0
    0
         Lost to follow-up
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    diet counselling (to assure appropriate vitamin D and calcium intake (1200–1500 mg of calcium and 800 mg of vitamin D per day)

    Reporting group title
    One year zoledronate group
    Reporting group description
    zoledronate (intravenous infusion; 5 mg/year) combined with diet counselling

    Reporting group title
    Two-year zoledronate group
    Reporting group description
    zoledronate (intravenous infusion; 5 mg/year during two years) combined with diet counselling

    Reporting group values
    Control group One year zoledronate group Two-year zoledronate group Total
    Number of subjects
    10 9 12 31
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0
        Adults (18-64 years)
    10 9 12 31
        From 65-84 years
    0 0 0 0
        85 years and over
    0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    48.6 (41.6 to 58.8) 46.4 (44.4 to 58.3) 49.4 (45.6 to 57.0) -
    Gender categorical
    Units: Subjects
        Female
    1 2 1 4
        Male
    9 7 11 27

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    diet counselling (to assure appropriate vitamin D and calcium intake (1200–1500 mg of calcium and 800 mg of vitamin D per day)

    Reporting group title
    One year zoledronate group
    Reporting group description
    zoledronate (intravenous infusion; 5 mg/year) combined with diet counselling

    Reporting group title
    Two-year zoledronate group
    Reporting group description
    zoledronate (intravenous infusion; 5 mg/year during two years) combined with diet counselling

    Primary: Changes in lumbar spine L1−L4 BMD

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    End point title
    Changes in lumbar spine L1−L4 BMD
    End point description
    End point type
    Primary
    End point timeframe
    From baseline to week 96
    End point values
    Control group One year zoledronate group Two-year zoledronate group
    Number of subjects analysed
    10
    9
    12
    Units: (g/cm2)
    median (inter-quartile range (Q1-Q3))
        baseline
    1.01 (0.95 to 1.10)
    0.93 (0.92 to 1.02)
    0.94 (0.89 to 1.06)
        week 48
    0.98 (0.91 to 1.10)
    0.99 (0.96 to 1.07)
    0.99 (0.95 to 1.10)
        week 96
    1.01 (0.95 to 1.09)
    0.98 (0.96 to 1.06)
    1.04 (0.96 to 1.10)
    Statistical analysis title
    Comparing Medians
    Statistical analysis description
    Comparin Baseline
    Comparison groups
    Control group v One year zoledronate group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.39
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians
    Statistical analysis description
    Comparing Baseline
    Comparison groups
    Control group v Two-year zoledronate group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.22
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians
    Statistical analysis description
    Comparing Baseline
    Comparison groups
    One year zoledronate group v Two-year zoledronate group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.97
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w48
    Statistical analysis description
    Week 48
    Comparison groups
    Control group v One year zoledronate group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.4
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w48
    Statistical analysis description
    Week48
    Comparison groups
    Control group v Two-year zoledronate group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.56
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w48
    Statistical analysis description
    Week 48
    Comparison groups
    One year zoledronate group v Two-year zoledronate group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.92
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w96
    Statistical analysis description
    Week 96
    Comparison groups
    Control group v One year zoledronate group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.22
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w96
    Statistical analysis description
    Week 96
    Comparison groups
    Control group v Two-year zoledronate group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.79
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w96
    Statistical analysis description
    Week 96
    Comparison groups
    One year zoledronate group v Two-year zoledronate group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.25
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Changes in total hip BMD

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    End point title
    Changes in total hip BMD
    End point description
    End point type
    Primary
    End point timeframe
    from baseline to week 96
    End point values
    Control group One year zoledronate group Two-year zoledronate group
    Number of subjects analysed
    10
    9
    12
    Units: g/cm2
    median (inter-quartile range (Q1-Q3))
        Baseline
    0.84 (0.82 to 0.88)
    0.82 (0.74 to 0.89)
    0.80 (0.78 to 0.89)
        week 48
    0.84 (0.80 to 0.90)
    0.85 (0.78 to 0.87)
    0.83 (0.81 to 0.91)
        week 96
    0.84 (0.83 to 0.90)
    0.84 (0.76 to 0.89)
    0.84 (0.82 to 0.95)
    Statistical analysis title
    Comparing Medians Bl
    Statistical analysis description
    Baseline
    Comparison groups
    Control group v One year zoledronate group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.49
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians Bl
    Statistical analysis description
    Baseline
    Comparison groups
    Control group v Two-year zoledronate group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.21
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians Bl
    Statistical analysis description
    Baseline
    Comparison groups
    One year zoledronate group v Two-year zoledronate group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.67
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w48
    Statistical analysis description
    Week 48
    Comparison groups
    Control group v One year zoledronate group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.88
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w48
    Statistical analysis description
    Week 48
    Comparison groups
    Control group v Two-year zoledronate group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.92
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w48
    Statistical analysis description
    Week 48
    Comparison groups
    One year zoledronate group v Two-year zoledronate group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.83
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w96
    Statistical analysis description
    Week 96
    Comparison groups
    Control group v One year zoledronate group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.96
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w96
    Statistical analysis description
    Week96
    Comparison groups
    Control group v Two-year zoledronate group
    Number of subjects included in analysis
    22
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.67
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    Comparing Medians w96
    Statistical analysis description
    eek 96
    Comparison groups
    One year zoledronate group v Two-year zoledronate group
    Number of subjects included in analysis
    21
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    = 0.52
    Method
    Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from baseline to 48 week follow up
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    DAIDS AE GRADING TAB
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    One year zoledronate group
    Reporting group description
    -

    Serious adverse events
    One year zoledronate group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    One year zoledronate group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 9 (44.44%)
    Nervous system disorders
    asthenia
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2
    Infections and infestations
    Fever
         subjects affected / exposed
    2 / 9 (22.22%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2008
    Number of patients enrolled decreased and randomization ratio changed
    12 Apr 2010
    Study design changed

    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.
    None reported
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