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    Clinical Trial Results:
    An Imaging Sub-Study of the Phase 3 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Odanacatib (MK-0822) to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women Treated With Vitamin D and Calcium

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2008-004578-42
    Trial protocol
    		 DK   CZ   EE  
    Global end of trial date
    11 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 May 2016
    First version publication date
    15 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-0822-032
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    11 Nov 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Nov 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was an Imaging Sub-Study of Protocol MK-0822-018, A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk. Study MK-0822-018 was an event-driven trial to determine the safety and efficacy, especially fracture-risk reduction, of odanacatib in postmenopausal women 65 years and older who have been diagnosed with osteoporosis. The main objective of this Imaging Sub-Study (MK-0822-032) was to evaluate the effect of treatment with MK-0822 50 mg once weekly on percent change from baseline in trabecular volumetric bone mineral density (vBMD) at the lumbar spine, compared to placebo at Month 24. The percent change was assessed using Quantitative Computed Tomography (QCT). The primary hypothesis was as follows: Compared to placebo, MK-0822 will increase trabecular vBMD at the lumbar spine (assessed by QCT) from baseline at Month 24.
    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
    		 Treatment of postmenopausal women with osteoporosis
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 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
    Denmark: 103
    Country: Number of subjects enrolled
    South Africa: 61
    Worldwide total number of subjects
    164
    EEA total number of subjects
    103
    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)
    0
    From 65 to 84 years
    160
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 This Sub-Study enrolled postmenopausal women with osteoporosis from Study MK-0822-018. Other inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 A total of 164 participants from Study MK-0822-018 were enrolled in Sub-Study MK-0822-032. Of those enrolled, 160 participants received treatment and were included in the All-Patients-Treated population.

    Period 1
    Period 1 title
    Overall Study (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 50 mg of blinded odanacatib once weekly over the course of Study MK-0822-018 and the first Extension (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that 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
    50 mg of odanacatib once weekly over the course of the Base study and first Extension

    Arm title
    		 Placebo once weekly
    Arm description
    		 Participants received placebo to odanacatib 50 mg weekly over the course of Study MK-0822-018 and the first Extension. Participants also received Vitamin D3 and open-label supplemental calcium so that 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
    50 mg placebo tablet to odanacatib once weekly over the course of the Base study and first Extension

    Number of subjects in period 1
    		Odanacatib 50 mg once weekly Placebo once weekly
    Started
    78
    86
    Completed
    57
    61
    Not completed
    21
    25
         Withdrawal By Subject
    3
    8
         Adverse event, non-fatal
    11
    7
         Other Protocol Specified Criteria
    6
    9
         Protocol deviation
    1
    -
         Lack of efficacy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Odanacatib 50 mg once weekly
    Reporting group description
    		 Participants received 50 mg of blinded odanacatib once weekly over the course of Study MK-0822-018 and the first Extension (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that 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 placebo to odanacatib 50 mg weekly over the course of Study MK-0822-018 and the first Extension. Participants also received Vitamin D3 and open-label supplemental calcium so that 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
    		 78 86 164
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.3 ± 5.7 72.9 ± 5.7 -
    Gender Categorical
    Units: Subjects
        Female
    		 78 86 164
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Odanacatib 50 mg once weekly
    Reporting group description
    		 Participants received 50 mg of blinded odanacatib once weekly over the course of Study MK-0822-018 and the first Extension (5 years total). Participants also received Vitamin D3 and open-label supplemental calcium so that 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 placebo to odanacatib 50 mg weekly over the course of Study MK-0822-018 and the first Extension. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg.

    Primary: Percent Change From Baseline in Spine (L1) Trabecular vBMD at Total Vertebral Body (mg/cm3) at Month 24

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    End point title
    		 Percent Change From Baseline in Spine (L1) Trabecular vBMD at Total Vertebral Body (mg/cm3) at Month 24
    End point description
    Trabecular vBMD of the lumbar spine was assessed using QCT at Baseline and at Months 12, 24, and 36. This endpoint was based on the full analysis set (FAS) population, which consisted of all randomized participants who received at least one dose of blinded study treatment, have a baseline measurement andat least one on-treatment measurement available.
    End point type
    Primary
    End point timeframe
    Baseline to Month 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    46
    48
    Units: Percent change
        least squares mean (confidence interval 95%)
    8.05 (4.48 to 11.62)
    -0.87 (-4.37 to 2.64)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    A longitudinal data analysis (LDA) model that included time points at Months 12, 24, and 36, and also factors for treatment, stratum (prior vertebral fracture [yes/no]) and the interaction of time by treatment, was used.
    Comparison groups
    Placebo once weekly v Odanacatib 50 mg once weekly
    Number of subjects included in analysis
    94
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 LDA model
    Parameter type
    		 Difference in LS Means
    Point estimate
    8.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 13.93

    Secondary: Percent Change From Baseline in QCT Total Hip Cortical vBMD (mg/cm3) at Month 24

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    End point title
    		 Percent Change From Baseline in QCT Total Hip Cortical vBMD (mg/cm3) at Month 24
    End point description
    Cortical vBMD of the hip was assessed using QCT at Baseline and at Months 12, 24, and 36. This endpoint was based on the full analysis set (FAS) population, which consisted of all randomized participants who received at least one dose of blinded study treatment, have a baseline measurement and at least one on-treatment measurement available.
    End point type
    Secondary
    End point timeframe
    Baseline to Month 24
    End point values
    		 Odanacatib 50 mg once weekly Placebo once weekly
    Number of subjects analysed
    51
    55
    Units: Percent change
        least squares mean (confidence interval 95%)
    3.29 (2.33 to 4.24)
    0.52 (-0.39 to 1.44)
    Statistical analysis title
    		 Difference in Least Squares Means
    Statistical analysis description
    LDA method that included time points at Months 12, 24, and 36 was used for analysis of QCT Total Hip Cortical vBMD.
    Comparison groups
    Odanacatib 50 mg once weekly v Placebo once weekly
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 LDA model
    Parameter type
    		 Difference in LS Means
    Point estimate
    2.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.43
         upper limit
    		 4.1

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    With the exception of the qualitative assessment of transilial bone biopsies, there were no safety assessments planned in the context of Sub-Study MK-0822-032. Participant safety assessments will be contained within Study MK-0822-018.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not applicable
    Dictionary version
    N/A
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: With the exception of the qualitative assessment of transilial bone biopsies, there were no safety assessments planned in the context of Sub-Study MK-0822-032. Participant safety assessments will be contained within Study MK-0822-018.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jun 2009
    Amendment 1: The primary reasons for this amendment were as follows: new information based on Denmark MSD site allocation of participants for Protocol 018; incorporated suggestions and requirements from regulatory agencies and ethics review committee during the protocol review and approval process for the "Lead Cohort"; and clarified protocol based on questions received from sites.

    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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