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    Clinical Trial Results:
    Primary hyperparathyroidism: does a systematic treatment improve the calcium- and bone metabolism after successful surgery? – Part Systematic treatment of osteopenic and osteoporotic postmenopausal patients after successful surgical treatment for primary hyperparathyroidism with Strontium ranelate

    Summary
    EudraCT number
    2008-001703-32
    Trial protocol
    AT  
    Global end of trial date
    31 Jan 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Feb 2019
    First version publication date
    13 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PHPT_001/08
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01222026
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria, 1090
    Public contact
    Martin Niederle, MD, Department of Surgery - Medical University of Vienna Prof. Bruno Niederle, MD, +43 1 40400 56210, martin.niederle@meduniwien.ac.at
    Scientific contact
    Martin Niederle, MD, Department of Surgery - Medical University of Vienna Prof. Bruno Niederle, MD, +43 1 40400 56210, martin.niederle@meduniwien.ac.at
    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
    01 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jan 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effect of Strontium ranelate and Calcium/Vitamin D on bone density and metabolism in patients after surgical cure of primary hyperparathyroidism.
    Protection of trial subjects
    All patients are monitored during routine investigations on a regular base. All subjects experiencing adverse events – whether considered associated with the study therapy or not – will be monitored until symptoms subside and any abnormal laboratory values have returned to baseline, or until there is a satisfactory explanation for the changes observed, or until death, in which case a full pathologist’s report will be supplied, if possible. All findings must be reported on an „Adverse event“ page in the case report form. All subjects names will be kept secret in the investigator’s files. Subjects will be identified throughout documentation and evaluation by the number allotted to them during the study. The subjects will be told that all study findings will be stored and handled in strictest confidence.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Nov 2010
    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
    Austria: 66
    Worldwide total number of subjects
    66
    EEA total number of subjects
    66
    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)
    32
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment period: 2010/11/10 until 2013/12/31 (38 months) Participants will be recruited by the Department of Surgery, Medical University of Vienna

    Pre-assignment
    Screening details
    All postmenopausal women and men with biochemically proven pHPT and osteopenia (t-score < -1 and > -2.5) or osteoporosis (t-score ≤ -2.5) visiting the Department of Surgery, Medical University of Vienna, between October 2010 and December 2013 were asked to participate in this study before PTX. Totally 358 patients were screened.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor
    Blinding implementation details
    Medication was coded and randomly numbered by the provider (Servier), delivered to the study center and then handed to the participants by the care providers in chronologic order (both kept blind, no special allocation to intervention groups but randomness). All participants, care providers and those assessing outcomes were kept blind until completion of data input at the end of the follow-up period. Then the medications’ codes were received from the provider and the trial was unblinded.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Treatment
    Arm description
    Receiving Strontium ranelate 2g per day + 1000mg Calcium + 800 IE Vitamin D
    Arm type
    Active comparator

    Investigational medicinal product name
    Strontium ranelate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules and solvent for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    2g daily for one year

    Arm title
    Placebo
    Arm description
    Receiving Placebo + 1000mg Calcium + 800 IE Vitamin D
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules for oral solution in sachet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo granules for 1 year

    Number of subjects in period 1
    Treatment Placebo
    Started
    34
    32
    Completed
    29
    23
    Not completed
    5
    9
         Protocol deviation
    2
    4
         Adverse event, non-fatal
    2
    3
         Lost to follow-up
    1
    2

    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
    66 66
    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
    Of all participants incl. those not finishing the trial (Final calculations were done as per protocol analysis)
    Units: years
        arithmetic mean (standard deviation)
    63 ± 11 -
    Gender categorical
    Of all participants incl. those not finishing the trial (Final calculations were done as per protocol analysis)
    Units: Subjects
        Female
    25 25
        Male
    41 41

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    Receiving Strontium ranelate 2g per day + 1000mg Calcium + 800 IE Vitamin D

    Reporting group title
    Placebo
    Reporting group description
    Receiving Placebo + 1000mg Calcium + 800 IE Vitamin D

    Primary: %-change BMD lumbar spine

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    End point title
    %-change BMD lumbar spine
    End point description
    End point type
    Primary
    End point timeframe
    1-year-control after starting to take study medciation (end of intervention)
    End point values
    Treatment Placebo
    Number of subjects analysed
    29
    23
    Units: percent
        arithmetic mean (standard deviation)
    9.94 ± 6.33
    3.94 ± 4.49
    Statistical analysis title
    t-test %-change BMD lumbar spine
    Comparison groups
    Treatment v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    t-test, 2-sided
    Confidence interval

    Primary: %-change BMD femoral neck

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    End point title
    %-change BMD femoral neck
    End point description
    End point type
    Primary
    End point timeframe
    1-year-control after starting to take study medciation (end of intervention)
    End point values
    Treatment Placebo
    Number of subjects analysed
    29
    23
    Units: percent
        arithmetic mean (standard deviation)
    5.87 ± 5.86
    4.84 ± 4.55
    Statistical analysis title
    t-test %-change BMD femoral neck
    Comparison groups
    Treatment v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.504
    Method
    t-test, 2-sided
    Confidence interval

    Primary: %-change BMD radius 1/3

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    End point title
    %-change BMD radius 1/3
    End point description
    End point type
    Primary
    End point timeframe
    1-year-control after starting to take study medciation (end of intervention)
    End point values
    Treatment Placebo
    Number of subjects analysed
    29
    23
    Units: percent
        arithmetic mean (standard deviation)
    0.42 ± 4.06
    0.00 ± 3.36
    Statistical analysis title
    t-test %-change BMD radius 1/3
    Comparison groups
    Treatment v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.69
    Method
    t-test, 2-sided
    Confidence interval

    Primary: %-change BMD radius MID

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    End point title
    %-change BMD radius MID
    End point description
    End point type
    Primary
    End point timeframe
    1-year-control after starting to take study medciation (end of intervention)
    End point values
    Treatment Placebo
    Number of subjects analysed
    29
    23
    Units: percent
        arithmetic mean (standard deviation)
    1.64 ± 3.23
    0.41 ± 2.86
    Statistical analysis title
    t-test %-change BMD radius MID
    Comparison groups
    Treatment v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.166
    Method
    t-test, 2-sided
    Confidence interval

    Primary: %-change BMD radius UD

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    End point title
    %-change BMD radius UD
    End point description
    End point type
    Primary
    End point timeframe
    1-year-control after starting to take study medciation (end of intervention)
    End point values
    Treatment Placebo
    Number of subjects analysed
    29
    23
    Units: percent
        arithmetic mean (standard deviation)
    3.02 ± 5.86
    1.84 ± 5.76
    Statistical analysis title
    t-test %-change BMD radius UD
    Comparison groups
    Treatment v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.474
    Method
    t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    1-year treatment period
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    icd
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Treatment
    Reporting group description
    Receiving Strontium ranelate 2g per day + 1000mg Calcium + 800 IE Vitamin D

    Reporting group title
    Placebo
    Reporting group description
    Receiving Placebo + 1000mg Calcium + 800 IE Vitamin D

    Serious adverse events
    Treatment Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Treatment Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 30 (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 non-serious adverse event exceeded the threshold-rate of 5% in both groups

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Apr 2013
    In accordance with European Medicines Agency regulations, additional exclusion criteria (ischemic cardiac disease, peripheral arterial obstructive disease, cerebrovascular disease, and uncontrolled arterial hypertonia) were added in April 2013. Since then, electrocardiograms were included in pre-study screening and were also performed after the 12-month study period.

    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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