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    Clinical Trial Results:
    A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to reduce the Risk of Fracture in Osteoporotic Men Treated with Vitamin D and Calcium

    Summary
    EudraCT number
    		 2010-019454-41
    Trial protocol
    		 LV   DK   GB   NL   EE   IT   BG  
    Global end of trial date
    22 Jul 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jul 2016
    First version publication date
    15 Jul 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    0822-053
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01120600
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    22 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jul 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To assess the effect in men with osteoporosis of odanacatib 50 mg once weekly versus placebo on lumbar spine bone mineral density (BMD) over 24 months; 2. To assess the safety and tolerability of odanacatib 50 mg once weekly compared to placebo.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Calcium and Vitamin D3
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jun 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
    Colombia: 20
    Country: Number of subjects enrolled
    Chile: 2
    Country: Number of subjects enrolled
    United States: 61
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Netherlands: 6
    Country: Number of subjects enrolled
    United Kingdom: 59
    Country: Number of subjects enrolled
    Denmark: 43
    Country: Number of subjects enrolled
    Estonia: 9
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Latvia: 11
    Country: Number of subjects enrolled
    Japan: 24
    Country: Number of subjects enrolled
    Mexico: 6
    Worldwide total number of subjects
    294
    EEA total number of subjects
    161
    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)
    77
    From 65 to 84 years
    210
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were men between 40 and 95 years of age, with idiopathic osteoporosis or osteoporosis due to hypogonadism. Additional inclusion and exclusion criteria applied.

    Period 1
    Period 1 title
    Period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Odanacatib 50 mg once weekly
    Arm description
    		 Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Odanacatib
    Investigational medicinal product code
    Other name
    MK-0822
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Odanacatib, 50 mg tablet, once weekly

    Arm title
    		 Placebo once weekly
    Arm description
    		 Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one placebo to Odanacatib tablet once weekly.

    Number of subjects in period 1
    		Odanacatib 50 mg once weekly Placebo once weekly
    Started
    147
    147
    Treated
    146
    146
    Completed
    128
    115
    Not completed
    19
    32
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    10
    11
         Physician decision
    1
    3
         Adverse event, non-fatal
    5
    6
         Excessive bone loss
    -
    4
         Lost to follow-up
    1
    3
         Protocol deviation
    -
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Odanacatib 50 mg once weekly
    Reporting group description
    		 Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.

    Reporting group title
    Placebo once weekly
    Reporting group description
    		 Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.

    Reporting group values
    		 Odanacatib 50 mg once weekly Placebo once weekly Total
    Number of subjects
    		 147 147 294
    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)
    		 40 37 77
        From 65-84 years
    		 103 107 210
        85 years and over
    		 4 3 7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.9 ± 8.2 68.7 ± 7.7 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 147 147 294

    End points

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    End points reporting groups
    Reporting group title
    Odanacatib 50 mg once weekly
    Reporting group description
    		 Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.

    Reporting group title
    Placebo once weekly
    Reporting group description
    		 Participants received one Placebo tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.

    Primary: Percentage Change from Baseline in Lumbar Spine Bone Mineral Density at Month 24

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    End point title
    		 Percentage Change from Baseline in Lumbar Spine Bone Mineral Density at Month 24
    End point description
    Lumbar spine BMD was assessed by dual energy X-ray absorptiometry (DXA) at Baseline and at Months 3, 6, 12, and 24. This endpoint was based on the full analysis set (FAS) population, which consisted of all randomized participants who took at least one dose of blinded study treatment. Participants without a baseline measurement for the endpoint were excluded.
    End point type
    Primary
    End point timeframe
    Baseline and Months 3, 6, 12, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    112
    107
    Units: percent change
        least squares mean (confidence interval 95%)
    6.86 (6.08 to 7.64)
    1.27 (0.48 to 2.06)
    Statistical analysis title
    		 Pct Change in Lumbar Spine BMD at Month 24
    Statistical analysis description
    A constrained full likelihood longitudinal data analysis (cLDA) method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type–by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in LS means
    Point estimate
    5.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.48
         upper limit
    		 6.7

    Secondary: Percentage Change from Baseline in Total Hip BMD at Month 24

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    End point title
    		 Percentage Change from Baseline in Total Hip BMD at Month 24
    End point description
    Total hip BMD was assessed by DXA at Baseline at Months 3, 6, 12, and 24. This endpoint was based on the FAS population, which consisted of all randomized participants who took at least one dose of blinded study treatment. Participants without a baseline measurement for the endpoint were excluded.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    111
    105
    Units: percent change
        least squares mean (confidence interval 95%)
    1.91 (1.38 to 2.43)
    -0.11 (-0.65 to 0.42)
    Statistical analysis title
    		 Pct Chg from Baseline in Total Hip BMD at Month 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    2.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 2.77

    Secondary: Percentage Change from Baseline in Femoral Neck BMD at Month 24

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    End point title
    		 Percentage Change from Baseline in Femoral Neck BMD at Month 24
    End point description
    Fermoral neck BMD was assessed by DXA at Baseline and at Months 3, 6, 12, and 24. This endpoint was based on the FAS population, which consisted of all randomized participants who took at least one dose of blinded study treatment. Participants without a baseline measurement for the endpoint were excluded.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    111
    105
    Units: percent change
        least squares mean (confidence interval 95%)
    1.69 (0.82 to 2.55)
    0 (-0.89 to 0.88)
    Statistical analysis title
    		 Pct Chg from Baseline in Fem Neck BMD at Month 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type–by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 2.93

    Secondary: Percentage Change from Baseline in Trochanter BMD at Month 24

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    End point title
    		 Percentage Change from Baseline in Trochanter BMD at Month 24
    End point description
    Trochanter BMD was assessed by DXA at Baseline and at Months 3, 6, 12, and 24. This endpoint was based on the FAS population, which consisted of all randomized participants who took at least one dose of blinded study treatment. Participants without a baseline measurement for the endpoint were excluded.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    111
    105
    Units: percent change
        least squares mean (confidence interval 95%)
    2.77 (1.94 to 3.6)
    0.66 (-0.18 to 1.5)
    Statistical analysis title
    		 Pct Chg from Baseline in Trochanter BMD at Mo 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model included the baseline measurement and all post-baseline percent changes from baseline in the response vector, with fixed effects for treatment, time, geographic region, machine type and treatment-by-time interaction, geographic region-by-time interaction, and machine type-by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    216
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    2.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 3.3

    Secondary: Percentage Change from Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24

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    End point title
    		 Percentage Change from Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 24
    End point description
    Serum samples were collected to evaluate biochemical markers for s-CTx, which were measured at Baseline and at Months 3, 6, 12, 18, and 24. This endpoint was based on the Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12, 18, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    112
    102
    Units: percent change
        least squares mean (confidence interval 95%)
    -20.07 (-28.36 to -10.82)
    56.51 (40.01 to 74.96)
    Statistical analysis title
    		 Pct Change from Baseline in s-CTx at Month 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model includes the log-transformed baseline and log-transformed post-baseline measurements up to Month 24 in the response vector, with fixed effects for treatment, time, geographic region, treatment-by-time interaction and geographic region-by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    214
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -76.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -92.56
         upper limit
    		 -60.61

    Secondary: Percentage Change from Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24

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    End point title
    		 Percentage Change from Baseline in Urine Collagen N-Telopeptide/Creatinine Ratio (U-NTx/Cr) at Month 24
    End point description
    Urine samples were collected to evaluate biochemical markers for u-NTx/Cr, which were measured at Baseline and at Months 3, 6, 12, 18, and 24. This endpoint was based on the Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12, 18, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    111
    102
    Units: percent change
        least squares mean (confidence interval 95%)
    -61.43 (-64.71 to -57.85)
    6.65 (-2.68 to 16.87)
    Statistical analysis title
    		 Pct Change from Baseline in u-NTx/Cr at Month 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model includes the log-transformed baseline and log-transformed post-baseline measurements up to Month 24 in the response vector, with fixed effects for treatment, time, geographic region, treatment-by-time interaction and geographic region-by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    213
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -68.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -78.1
         upper limit
    		 -58.06

    Secondary: Percentage Change from Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24

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    End point title
    		 Percentage Change from Baseline in Serum Bone-Specific Alkaline Phosphatase (s-BSAP) at Month 24
    End point description
    Biochemical markers for s-BSAP were measured at Baseline and at Months 3, 6, 12, 18, and 24. This endpoint was based on the Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results.
    End point type
    Secondary
    End point timeframe
    Months 3, 6, 12, 18, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    114
    110
    Units: percent change
        least squares mean (confidence interval 95%)
    -5.28 (-9.76 to -0.57)
    2.66 (-2.25 to 7.82)
    Statistical analysis title
    		 Pct Change From Baseline in s-BSAP at Month 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model includes the log-transformed baseline and log-transformed post-baseline measurements up to Month 24 in the response vector, with fixed effects for treatment, time, geographic region, treatment-by-time interaction and geographic region-by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.019
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -7.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.58
         upper limit
    		 -1.31

    Secondary: Percentage Change from Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24

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    End point title
    		 Percentage Change from Baseline in Serum N-Terminal Propeptides of Type I Collagen (s-P1NP) at Month 24
    End point description
    Serum samples were collected to evaluated biochemical markers for s-P1NP, which were measured at Baseline and at Months 3, 6, 12, 18, and 24. This endpoint was based on the Per-Protocol (PP) population, which excluded participants due to important deviations from the protocol that may have substantially affected the results.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6, 12, 18, and 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    114
    110
    Units: percent change
        least squares mean (confidence interval 95%)
    -10.94 (-17.27 to -4.14)
    5.06 (-2.47 to 13.17)
    Statistical analysis title
    		 Pct Change from Baseline in s-P1NP at Month 24
    Statistical analysis description
    A cLDA method was used for this statistical analysis. The cLDA model includes the log-transformed baseline and log-transformed post-baseline measurements up to Month 24 in the response vector, with fixed effects for treatment, time, geographic region, treatment-by-time interaction and geographic region-by-time interaction.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    224
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in LS Means
    Point estimate
    -16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.74
         upper limit
    		 -6.27

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 Months after first dose of study drug
    Adverse event reporting additional description
    Safety analyses were performed using the All-Patients-as-Treated (APaT) population, which included all participants who took at least one dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo once weekly
    Reporting group description
    		 -

    Reporting group title
    Odanacatib 50 mg once weekly
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo once weekly Odanacatib 50 mg once weekly
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 146 (17.81%)
    26 / 146 (17.81%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multi-organ failure
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat exhaustion
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative hernia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus ureteric
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         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
    Back pain
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 146 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 146 (0.68%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal infection
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo once weekly Odanacatib 50 mg once weekly
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 146 (30.14%)
    30 / 146 (20.55%)
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    9 / 146 (6.16%)
    4 / 146 (2.74%)
         occurrences all number
    11
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    10 / 146 (6.85%)
    4 / 146 (2.74%)
         occurrences all number
    11
    4
    Back pain
         subjects affected / exposed
    12 / 146 (8.22%)
    9 / 146 (6.16%)
         occurrences all number
    15
    11
    Pain in extremity
         subjects affected / exposed
    10 / 146 (6.85%)
    3 / 146 (2.05%)
         occurrences all number
    12
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    15 / 146 (10.27%)
    14 / 146 (9.59%)
         occurrences all number
    18
    18

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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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