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    Clinical Trial Results:
    Comparison of the Effects of Teriparatide with those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women with Low Bone Mass and a Recent Pertrochanteric Hip Fracture

    Summary
    EudraCT number
    		 2008-002693-35
    Trial protocol
    		 DK   DE   GB   ES   IT   GR   SE   AT   FR   CZ   IE   FI   NO  
    Global end of trial date
    20 Aug 2015

    Results information
    Results version number
    		 v1
    This version publication date
    31 Jul 2016
    First version publication date
    31 Jul 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    12400
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00887354
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: B3D-EW-GHDK, Trial ID: 12400
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon-Fri 9AM-5PM EST, Eli Lilly and Company, +1 877-CTLilly,
    Scientific contact
    Available Mon-Fri 9AM-5PM EST, Eli Lilly and Company, +1 877-285-4559,
    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
    20 Aug 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.
    Protection of trial subjects
    This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Apr 2009
    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
    France: 13
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Spain: 40
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Greece: 7
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Norway: 7
    Country: Number of subjects enrolled
    Denmark: 22
    Country: Number of subjects enrolled
    Italy: 26
    Country: Number of subjects enrolled
    Mexico: 18
    Worldwide total number of subjects
    171
    EEA total number of subjects
    146
    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)
    12
    From 65 to 84 years
    131
    85 years and over
    28

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Full Analysis Set (FAS) is defined as all randomized participants receiving at least one dose of study drug with at least one post-baseline efficacy measure.

    Period 1
    Period 1 title
    Treatment Phase (Week 0 to Week 26)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Teriparatide
    Arm description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection treatment phase throughout study (Week 0 to Week 26). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teriparatide
    Investigational medicinal product code
    Other name
    LY333334, Forteo, Forsteo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 micrograms (mcg) a day by subcutaneous injection throughout study.

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Investigational medicinal product name
    Oral Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weekly 35mg oral placebo

    Arm title
    		 Risedronate
    Arm description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Risedronate
    Investigational medicinal product code
    Other name
    Actonel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    35 milligrams (mg) risedronate sodium orally once weekly throughout study.

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Investigational medicinal product name
    Daily Placebo Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo 20 micrograms (mcg) daily

    Number of subjects in period 1
    		Teriparatide Risedronate
    Started
    111
    113
    Included in Full Analysis Set
    86
    85
    Completed
    86
    85
    Not completed
    25
    28
         Lack of efficacy
    20
    25
         Not treated
    5
    3
    Period 2
    Period 2 title
    Treatment Phase FAS (Week 0 to Week 26)
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Teriparatide
    Arm description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection throughout study (FAS Week 0 to Week 26). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teriparatide
    Investigational medicinal product code
    Other name
    LY333334, Forteo, Forsteo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 micrograms (mcg) a day by subcutaneous injection throughout study.

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Investigational medicinal product name
    Oral Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Weekly 35mg oral placebo

    Arm title
    		 Risedronate
    Arm description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Risedronate
    Investigational medicinal product code
    Other name
    Actonel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    35 mg risedronate sodium orally once weekly throughout study.

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Investigational medicinal product name
    Daily Placebo Injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo 20 micrograms (mcg) daily

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Period 1 accounts for the number of participants who were randomized and received at least one dose of study drug. Period 2 is the baseline period as it reports the efficacy results based on the FAS population, which is defined as those participants who received at least one dose of study drug with at least one post-baseline efficacy measure.
    Number of subjects in period 2
    		Teriparatide Risedronate
    Started
    86
    85
    Completed
    60
    65
    Not completed
    26
    20
         Physician decision
    2
    1
         Consent withdrawn by subject
    14
    8
         Adverse event, non-fatal
    3
    3
         Death
    -
    1
         Caregiver decision
    1
    2
         Sponsor decision
    1
    1
         Lost to follow-up
    2
    1
         Entry criteria not met
    3
    3
    Period 3
    Period 3 title
    Open Label Phase (Week 26 to Week 78)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Teriparatide
    Arm description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection throughout study (Open Label Phase Week 26 to Week 78). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Teriparatide
    Investigational medicinal product code
    Other name
    LY333334, Forteo, Forsteo
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 micrograms (mcg) a day by subcutaneous injection throughout study.

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Arm title
    		 Risedronate
    Arm description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Risedronate
    Investigational medicinal product code
    Other name
    Actonel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    35 milligrams (mg) risedronate sodium orally once weekly throughout study.

    Investigational medicinal product name
    Calcium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Investigational medicinal product name
    Vitamin D
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Number of subjects in period 3
    		Teriparatide Risedronate
    Started
    60
    65
    Completed
    57
    59
    Not completed
    3
    6
         Consent withdrawn by subject
    1
    2
         Physician decision
    -
    1
         Adverse event, non-fatal
    1
    -
         Death
    -
    2
         Lost to follow-up
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Teriparatide
    Reporting group description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection throughout study (FAS Week 0 to Week 26). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Reporting group title
    Risedronate
    Reporting group description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Reporting group values
    		 Teriparatide Risedronate Total
    Number of subjects
    		 86 85 171
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 8 4 12
        From 65-84 years
    		 62 69 131
        85 years and over
    		 16 12 28
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 77.2 ( 7.96 ) 76.4 ( 7.47 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 66 66 132
        Male
    		 20 19 39
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 86 85 171
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Region of Enrollment
    Number of participants for Country/Region of Enrollment reflects FAS population.
    Units: Subjects
        Greece
    		 3 4 7
        Canada
    		 0 2 2
        Czech Republic
    		 8 12 20
        United States
    		 1 4 5
        Norway
    		 5 2 7
        Denmark
    		 13 9 22
        Italy
    		 16 10 26
        Mexico
    		 6 12 18
        France
    		 5 8 13
        Germany
    		 2 1 3
        Spain
    		 21 19 40
        United Kingdom
    		 1 0 1
        Austria
    		 1 0 1
        Ireland
    		 1 0 1
        Sweden
    		 3 2 5

    End points

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    End points reporting groups
    Reporting group title
    Teriparatide
    Reporting group description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection treatment phase throughout study (Week 0 to Week 26). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Reporting group title
    Risedronate
    Reporting group description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Reporting group title
    Teriparatide
    Reporting group description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection throughout study (FAS Week 0 to Week 26). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Reporting group title
    Risedronate
    Reporting group description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Reporting group title
    Teriparatide
    Reporting group description
    		 20 microgram (mcg) a day by subcutaneous (SC) injection throughout study (Open Label Phase Week 26 to Week 78). Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Reporting group title
    Risedronate
    Reporting group description
    		 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Primary: Change in Lumbar Spine Areal Bone Mineral Density

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    End point title
    		 Change in Lumbar Spine Areal Bone Mineral Density
    End point description
    Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treament and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
    End point type
    Primary
    End point timeframe
    Baseline, Week 78
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    61 [1]
    66 [2]
    Units: gram per square centimeter (g/cm^2)
        least squares mean (standard error)
    0.094 ( 0.0075 )
    0.055 ( 0.0081 )
    Notes
    [1] - Post-Baseline Efficacy data was collected for 61 Participants of the 86 participants in the FAS.
    [2] - Post-Baseline Efficacy data was collected for 66 Participants of the 85 participants in the FAS.
    Statistical analysis title
    		 Primary Endpoint Statistical Analysis
    Comparison groups
    Teriparatide v Risedronate
    Number of subjects included in analysis
    127
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.025
         upper limit
    		 0.055

    Secondary: Change in Lumbar Spine Areal Bone Mineral Density

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    End point title
    		 Change in Lumbar Spine Areal Bone Mineral Density
    End point description
    Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26 and Baseline, Week 52
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    61 [3]
    66 [4]
    Units: g/cm^2
    least squares mean (standard error)
        Week 26
    0.053 ( 0.0074 )
    0.032 ( 0.0081 )
        Week 52
    0.078 ( 0.0074 )
    0.044 ( 0.0081 )
    Notes
    [3] - Post-baseline efficacy data was collected for 61 participants of the 86 participants of the FAS.
    [4] - Post-baseline efficacy data was collected for 66 participants or the 85 participants of the FAS.
    No statistical analyses for this end point

    Secondary: Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb

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    End point title
    		 Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
    End point description
    Change from baseline in areal bone mineral density at the femoral Neck/Total Hip of the non-fractured limb at 26 weeks, 52 weeks and 78 weeks. Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 26; Baseline, Week 52; Baseline, Week 78
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    60 [5]
    61 [6]
    Units: g/cm^2
    least squares mean (standard error)
        Total Hip 26 Weeks
    -0.001 ( 0.0042 )
    -0.001 ( 0.0042 )
        Total Hip 52 Weeks
    0.001 ( 0.0042 )
    -0.001 ( 0.0042 )
        Total Hip 78 Weeks
    0.007 ( 0.0042 )
    0.005 ( 0.0043 )
        Femoral Neck 26 Weeks
    0.002 ( 0.0044 )
    -0.009 ( 0.0043 )
        Femoral Neck 52 Weeks
    0 ( 0.0044 )
    -0.006 ( 0.0044 )
        Femoral Neck 78 Weeks
    0.012 ( 0.0044 )
    -0.007 ( 0.0045 )
    Notes
    [5] - Post-baseline efficacy data was collected for 60 participants of 86 participants in the FAS.
    [6] - Post-baseline efficacy data was collected for 61 participants of 85 participants in the FAS.
    No statistical analyses for this end point

    Secondary: Short form-36 (SF-36) Questionnaire

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    End point title
    		 Short form-36 (SF-36) Questionnaire
    End point description
    SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100).
    End point type
    Secondary
    End point timeframe
    Baseline, 6, 12, 18, and 26 Weeks of Treatment
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    67 [7]
    65 [8]
    Units: units on a scale
    least squares mean (standard error)
        Baseline, Week 6
    7.37 ( 1.065 )
    5.1 ( 1.087 )
        Baseline, Week 12
    11.32 ( 1.207 )
    11.09 ( 1.208 )
        Baseline, Week 18
    14.37 ( 1.256 )
    12.81 ( 1.26 )
        Baseline, Week 26
    16.34 ( 1.278 )
    14.36 ( 1.258 )
    Notes
    [7] - Post-baseline efficacy data was collected for 67 participants of 86 participants in the FAS.
    [8] - Post-baseline efficacy data was collected for 65 participants of 85 participants in the FAS.
    No statistical analyses for this end point

    Secondary: Timed "Up and Go" Test

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    End point title
    		 Timed "Up and Go" Test
    End point description
    Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley’s pain score.
    End point type
    Secondary
    End point timeframe
    6, 12, 18, and 26 Weeks
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    79 [9]
    78 [10]
    Units: seconds (sec)
    least squares mean (standard error)
        Week 6
    26.45 ( 1.09 )
    32.38 ( 1.085 )
        Week 12
    20.13 ( 1.092 )
    24.48 ( 1.086 )
        Week 18
    17.75 ( 1.093 )
    21.14 ( 1.087 )
        Week 26
    16.69 ( 1.095 )
    19.91 ( 1.088 )
    Notes
    [9] - Post-baseline efficacy data was collected for 79 participants of 86 participants in the FAS.
    [10] - Post-baseline efficacy data was collected for 78 participants of 85 participants in the FAS.
    No statistical analyses for this end point

    Secondary: Visual Analog Scale

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    End point title
    		 Visual Analog Scale
    End point description
    Visual Analog Scale (VAS): VAS-pain scale consists of 6 questions that assessed overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rated pain on a 100 millimeter (mm) line between two anchors (0= no pain and 100=very severe pain). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.
    End point type
    Secondary
    End point timeframe
    6, 12, 18, and 26 Weeks
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    63 [11]
    62 [12]
    Units: millimeter (mm)
    least squares mean (standard error)
        Week 6
    16.44 ( 3.977 )
    23.54 ( 4.443 )
        Week 12
    9.28 ( 4.048 )
    19.24 ( 4.452 )
        Week 18
    6.9 ( 4.147 )
    18.19 ( 4.508 )
        Week 26
    4.48 ( 4.128 )
    13.74 ( 4.505 )
    Notes
    [11] - Post-baseline efficacy data was collected for 63 participants of 86 participants in the FAS.
    [12] - Post-baseline efficacy data was collected for 62 participants of 85 participants in the FAS.
    No statistical analyses for this end point

    Secondary: Modification of the Charnley's Pain Scale

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    End point title
    		 Modification of the Charnley's Pain Scale
    End point description
    Self-reported pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous. Self-reported pain at the hip was measured with Charnley's Hip Score using a logistic regression with repeated measures to model the probability of a positive outcome and odds with 95% confidence intervals. Odds are presented as a number accompanied by confidence intervals in parenthesis.
    End point type
    Secondary
    End point timeframe
    Time Frame: Baseline, 6, 12, 18, and 26 Weeks
    End point values
    		 Teriparatide Risedronate
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: Odds and Odds Ratio
    number (confidence interval 95%)
        Baseline
    ( to )
    ( to )
        Week 6
    ( to )
    ( to )
        Week 12
    ( to )
    ( to )
        Week 18
    ( to )
    ( to )
        Week 26
    ( to )
    ( to )
    Notes
    [13] - No data displayed because Outcome Measure has zero total participants analyzed.
    [14] - No data displayed because Outcome Measure has zero total participants analyzed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment
    Adverse event reporting additional description
    B3D-EW-GHDK
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Risedronate
    Reporting group description
    		 -

    Reporting group title
    Teriparatide
    Reporting group description
    		 -

    Serious adverse events
    		 Risedronate Teriparatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 110 (24.55%)
    21 / 106 (19.81%)
         number of deaths (all causes)
    7
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    pancreatic carcinoma metastatic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular disorders
    aortic stenosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    orthostatic hypotension
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    venous thrombosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    death
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    device breakage
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device failure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    medical device complication
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    bronchial polyp
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    delirium
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    9 / 110 (8.18%)
    6 / 106 (5.66%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    femoral neck fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    forearm fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    head injury
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 110 (3.64%)
    2 / 106 (1.89%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    humerus fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pelvic fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    bradycardia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    mitral valve incompetence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    amnesia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebral infarction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    monoplegia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    speech disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    retinal detachment
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    oedema mouth
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    liver disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 106 (2.83%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    back pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    gastroenteritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    septic shock
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    subcutaneous abscess
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 106 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    wound infection staphylococcal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 106 (0.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Risedronate Teriparatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 110 (42.73%)
    53 / 106 (50.00%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    5 / 106 (4.72%)
         occurrences all number
    2
    5
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed [1]
    1 / 23 (4.35%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    vulval ulceration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed [2]
    1 / 87 (1.15%)
    0 / 106 (0.00%)
         occurrences all number
    1
    0
    vulvovaginal dryness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed [3]
    0 / 110 (0.00%)
    1 / 81 (1.23%)
         occurrences all number
    0
    1
    Psychiatric disorders
    delirium
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    2
    depression
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 110 (2.73%)
    1 / 106 (0.94%)
         occurrences all number
    3
    1
    insomnia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    Investigations
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    2
    platelet count increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    2
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    5 / 110 (4.55%)
    7 / 106 (6.60%)
         occurrences all number
    5
    8
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    2 / 106 (1.89%)
         occurrences all number
    1
    2
    headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 106 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    3 / 106 (2.83%)
         occurrences all number
    1
    3
    constipation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 110 (2.73%)
    2 / 106 (1.89%)
         occurrences all number
    3
    2
    diarrhoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 106 (2.83%)
         occurrences all number
    0
    3
    nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    6
    Skin and subcutaneous tissue disorders
    eczema
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    2
    rash
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 106 (0.94%)
         occurrences all number
    2
    1
    Renal and urinary disorders
    urinary incontinence
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 106 (0.94%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    7 / 110 (6.36%)
    12 / 106 (11.32%)
         occurrences all number
    8
    16
    back pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 110 (2.73%)
    3 / 106 (2.83%)
         occurrences all number
    3
    6
    bone pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    0 / 106 (0.00%)
         occurrences all number
    2
    0
    groin pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 106 (0.94%)
         occurrences all number
    2
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    2 / 106 (1.89%)
         occurrences all number
    1
    2
    osteoarthritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    2 / 106 (1.89%)
         occurrences all number
    2
    2
    pain in extremity
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    3 / 106 (2.83%)
         occurrences all number
    3
    7
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    4 / 106 (3.77%)
         occurrences all number
    0
    4
    gastroenteritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    2 / 106 (1.89%)
         occurrences all number
    0
    2
    influenza
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 110 (0.91%)
    2 / 106 (1.89%)
         occurrences all number
    1
    2
    nasopharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    2 / 106 (1.89%)
         occurrences all number
    2
    2
    urinary tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    4 / 110 (3.64%)
    7 / 106 (6.60%)
         occurrences all number
    7
    7
    viral infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 110 (0.00%)
    3 / 106 (2.83%)
         occurrences all number
    0
    4
    Metabolism and nutrition disorders
    hypercalcaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 110 (1.82%)
    1 / 106 (0.94%)
         occurrences all number
    2
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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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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