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    Clinical Trial Results:
    Knee joint replacement over 5 years in patients with knee osteoarthritis. A long term follow up study in patients of the CL3-12911-018 study.

    Summary
    EudraCT number
    		 2011-004046-18
    Trial protocol
    		 CZ   DE   AT   BE   PL   ES   IT   DK   LT   PT  
    Global end of trial date
    30 Jun 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CL3-12911-040
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes, France, 92284
    Public contact
    Therapeutic Innovation pole, Institut de Recherches Internationales Servier , 0033 0155724366, clinicaltrials@servier.com
    Scientific contact
    Therapeutic Innovation pole, Institut de Recherches Internationales Servier , 0033 0155724366, clinicaltrials@servier.com
    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 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To collect data on knee joint replacement procedures or procedures practiced in the knee (arthroscopy, osteotomy or other) over 5 years in patients with knee osteoarthritis having participated in the CL3-12911-018 study and having received at least one year (365 days) of CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo).
    Protection of trial subjects
    A patient could be prematurely and definitively discontinued from the study for medical (i.e. any new medical condition that may prevent the patient’s study participation) or or non-medical reason (including participant’s consent withdrawal) or patient lost to follow-up.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 71
    Country: Number of subjects enrolled
    Portugal: 4
    Country: Number of subjects enrolled
    Spain: 96
    Country: Number of subjects enrolled
    Austria: 27
    Country: Number of subjects enrolled
    Belgium: 69
    Country: Number of subjects enrolled
    Czech Republic: 23
    Country: Number of subjects enrolled
    Denmark: 151
    Country: Number of subjects enrolled
    France: 42
    Country: Number of subjects enrolled
    Germany: 21
    Country: Number of subjects enrolled
    Italy: 68
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Australia: 21
    Country: Number of subjects enrolled
    Canada: 149
    Country: Number of subjects enrolled
    Estonia: 26
    Country: Number of subjects enrolled
    Netherlands: 12
    Country: Number of subjects enrolled
    Romania: 7
    Country: Number of subjects enrolled
    Russian Federation: 39
    Country: Number of subjects enrolled
    United Kingdom: 47
    Worldwide total number of subjects
    878
    EEA total number of subjects
    669
    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)
    303
    From 65 to 84 years
    569
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 In all, 75 centres in 18 countries from the CL3-12911-018 study (having received at least one year of study treatment) included 878 patients.

    Pre-assignment
    Screening details
    		 Of the 1206 patients included in the CL3-12911-018 study with at least one year of study treatment, 878 patients were included in the present study: 288 patients in the former SrRan 1 g group, 296 patients in the former SrRan 2 g group, and 294 patients in the former placebo group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Former SrRan 1 g
    Arm description
    		 Patients received at least one year (365 days) of treatment of strontium ranelate 1 g during the CL3-12911-018 study, i.e. called in the present study former SrRan 1 g.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Strontium ranelate 1g
    Investigational medicinal product code
    S12911
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet of granules containing 1g of strontium ranelate had to be taken daily in the evening at bedtime preferably 2 hours after eating. The content of the sachet was to be mixed with at least 50 mL of tap water (approximately third of a glass) and the suspension obtained should be taken immediately. The sachet should not be taken with meals, calcium or drinks containing milk or calcium.

    Arm title
    		 Former SrRan 2 g
    Arm description
    		 Patients received at least one year (365 days) of treatment of strontium ranelate 2 g during the CL3-12911-018 study, i.e. called in the present study former SrRan 2 g.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Strontium ranelate 2g
    Investigational medicinal product code
    S12911
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet of granules containing 2g of strontium ranelate had to be taken daily in the evening at bedtime preferably 2 hours after eating. The content of the sachet was to be mixed with at least 50 mL of tap water (approximately third of a glass) and the suspension obtained should be taken immediately. The sachet should not be taken with meals, calcium or drinks containing milk or calcium.

    Arm title
    		 Former Placebo
    Arm description
    		 Patients received at least one year (365 days) of Placebo during the CL3-12911-018 study, i.e. called in the present study former Placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet of granules containing placebo had to be taken daily in the evening at bedtime preferably 2 hours after eating. The content of the sachet was to be mixed with at least 50 mL of tap water (approximately third of a glass) and the suspension obtained should be taken immediately. The sachet should not be taken with meals, calcium or drinks containing milk or calcium.

    Number of subjects in period 1
    		Former SrRan 1 g Former SrRan 2 g Former Placebo
    Started
    288
    296
    294
    Completed
    6
    5
    5
    Not completed
    282
    291
    289
         Study termination
    269
    281
    273
         Medical reason
    5
    1
    3
         Lost to follow-up
    8
    9
    10
         Non-medical reason
    -
    -
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole study period
    Reporting group description
    		 -

    Reporting group values
    		 Whole study period Total
    Number of subjects
    		 878 878
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 303 303
        From 65-84 years
    		 569 569
        85 years and over
    		 6 6
    Gender categorical
    Units: Subjects
        Female
    		 618 618
        Male
    		 260 260
    Subject analysis sets

    Subject analysis set title
    Included Set follow-up
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients in the CL3-12911-018 study who are included in the follow-up study.

    Subject analysis sets values
    		 Included Set follow-up
    Number of subjects
    878
    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)
    303
        From 65-84 years
    569
        85 years and over
    6
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Units: Subjects
        Female
    618
        Male
    260

    End points

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    End points reporting groups
    Reporting group title
    Former SrRan 1 g
    Reporting group description
    		 Patients received at least one year (365 days) of treatment of strontium ranelate 1 g during the CL3-12911-018 study, i.e. called in the present study former SrRan 1 g.

    Reporting group title
    Former SrRan 2 g
    Reporting group description
    		 Patients received at least one year (365 days) of treatment of strontium ranelate 2 g during the CL3-12911-018 study, i.e. called in the present study former SrRan 2 g.

    Reporting group title
    Former Placebo
    Reporting group description
    		 Patients received at least one year (365 days) of Placebo during the CL3-12911-018 study, i.e. called in the present study former Placebo.

    Subject analysis set title
    Included Set follow-up
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All randomised patients in the CL3-12911-018 study who are included in the follow-up study.

    Primary: Knee joint replacement and other knee surgery/procedure

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    End point title
    		 Knee joint replacement and other knee surgery/procedure [1]
    End point description
    End point type
    Primary
    End point timeframe
    The evaluation criterion was the number of patients who underwent a knee joint replacement defined as a surgery for total prosthesis and/or partial prosthesis.
    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: The study has been prematurely stopped due to strategic reasons, therefore changes have been decided in the statistical analysis : descriptive statistics (quantitative, qualitative) were provided by treatment group depending on the nature of the criteria.
    End point values
    		 Former SrRan 1 g Former SrRan 2 g Former Placebo
    Number of subjects analysed
    288 [2]
    296 [3]
    294 [4]
    Units: Number of patient
    26
    32
    27
    Notes
    [2] - Included Set follow-up
    [3] - Included Set follow-up
    [4] - Included Set follow-up
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    As no medicinal investigational product was delivered and no study specific procedure was planned, no adverse event was expected to be collected.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Former SrRan 1 g
    Reporting group description
    		 As no medicinal investigational product was delivered and no study specific procedure was planned, no adverse event was expected to be collected.

    Reporting group title
    Former SrRan 2 g
    Reporting group description
    		 As no medicinal investigational product was delivered and no study specific procedure was planned, no adverse event was expected to be collected.

    Reporting group title
    Former Placebo
    Reporting group description
    		 As no medicinal investigational product was delivered and no study specific procedure was planned, no adverse event was expected to be collected.

    Serious adverse events
    		 Former SrRan 1 g Former SrRan 2 g Former Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 296 (0.00%)
    0 / 294 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Former SrRan 1 g Former SrRan 2 g Former Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 288 (0.00%)
    0 / 296 (0.00%)
    0 / 294 (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: As no medicinal investigational product was delivered and no study specific procedure was planned, no adverse event was expected to be collected.

    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? Yes
    Date
    Interruption
    Restart date
    19 Mar 2014
    The study was prematurely discontinued by the sponsor in relation with strategic reasons. The follow-up of the study lasted at maximum 24 months.
    -

    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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