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    Clinical Trial Results:
    A multicentre, open label study to evaluate the safety and efficacy of Alendros 70 therapy administered 70mg once a week in women with postmenopausal osteoporosis

    Summary
    EudraCT number
    		 2005-002342-19
    Trial protocol
    		 CZ  
    Global end of trial date
    28 May 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    07/05/ALE/TP4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zentiva, a.s.
    Sponsor organisation address
    U Kabelovny 130, Prague 10, Czech Republic, 10237
    Public contact
    Tomas Hauser, MD, Zentiva, a.s., +420 267 243 451, tomas.hauser@sanofi.com
    Scientific contact
    Tomas Hauser, MD, Zentiva, a.s., +420 267 243 451, tomas.hauser@sanofi.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
    28 May 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    28 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the safety profile of alendronat 70mg administered once a week in this patient population based on adverse event incidence and changes in laboratory profiles
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2005
    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
    Czech Republic: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 2 centers in the Czech Republic - Osteocentrum in Hradec Kralove and Osteologicke centrum in Brno

    Pre-assignment
    Screening details
    		 inclusion criteria: Woman in ambulatory treatment Age up to 80 years Postmenopausal osteoposis DXA criteria of osteoporosis (T score L of bone in at least 2 evaluable spondyles or with proximal femur  -2.5) Signed informed consent

    Period 1
    Period 1 title
    Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    design: Multicentric, open intervential clinical trial phase IV with one arm

    Arms
    Arm title
    		 Main Arm
    Arm description
    		 one arm: multicentric, open intervential clinical trial phase IV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alendros 70 mg (alendronate)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    70 mg of alendronate (1 tbl.) per week. duration: 1 year

    Number of subjects in period 1
    		Main Arm
    Started
    100
    Completed
    75
    Not completed
    25
         Protocol deviation
    25

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period
    Reporting group description
    		 -

    Reporting group values
    		 Period Total
    Number of subjects
    		 100 100
    Age categorical
    women with postmenopausal osteoporosis
    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)
    		 100 100
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    women with postmenopausal osteoporosis
    Units: years
        arithmetic mean (standard deviation)
    		 65.11 ( 7.29 ) -
    Gender categorical
    Units: Subjects
        Female
    		 100 100
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Main Arm
    Reporting group description
    		 one arm: multicentric, open intervential clinical trial phase IV

    Primary: Safety evaluation - number of subjects affected by AEs

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    End point title
    		 Safety evaluation - number of subjects affected by AEs [1]
    End point description
    End point type
    Primary
    End point timeframe
    AEs from the whole 1 year study
    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: intervential CT
    End point values
    		 Main Arm
    Number of subjects analysed
    100
    Units: adverse events experienced
    69
    No statistical analyses for this end point

    Primary: Safety evaluation - number of AEs

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    End point title
    		 Safety evaluation - number of AEs [2]
    End point description
    End point type
    Primary
    End point timeframe
    the whole study
    Notes
    [2] - 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: intervential CT
    End point values
    		 Main Arm
    Number of subjects analysed
    100
    Units: number of adverse events
    154
    No statistical analyses for this end point

    Secondary: DXA loin value

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    End point title
    		 DXA loin value
    End point description
    End point type
    Secondary
    End point timeframe
    the whole study
    End point values
    		 Main Arm
    Number of subjects analysed
    75
    Units: g/cm^2
        arithmetic mean (standard deviation)
    0.74 ( 0.1 )
    No statistical analyses for this end point

    Secondary: DXA femur value

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    End point title
    		 DXA femur value
    End point description
    End point type
    Secondary
    End point timeframe
    the whole study
    End point values
    		 Main Arm
    Number of subjects analysed
    75
    Units: g/cm^2
        arithmetic mean (standard deviation)
    0.74 ( 0.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    the whole study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Adverse events
    Reporting group description
    		 all the patients

    Serious adverse events
    		 Adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 100 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    bleeding from lungs
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    arterial bleeding - complication of polypectomy
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    stroke
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Quadriparesis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    suspect Wegener granulomatosis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    ovarian cystoma (gynecological operation)
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    gynecological bleeding
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    planned operation of gallbladder (cholecystectomy)
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    planned surgery - parathyroid adenoma
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    total hip replacement
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    extraction of metal from elbow
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    total knee replacement
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    rehabilitation therapy
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    acute appendicitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    appendectomy
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 100 (59.00%)
    General disorders and administration site conditions
    154 non-adverse events
    Additional description: there were 154 non-serious adverse events within the study
         subjects affected / exposed
    59 / 100 (59.00%)
         occurrences all number
    154

    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.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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