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    Summary
    EudraCT Number:2008-005874-11
    Sponsor's Protocol Code Number:0822-035
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-19
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2008-005874-11
    A.3Full title of the trial
    A Substudy to Explore Biomarkers of Physical Function in the 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 Postmenopausal Women Treated with Vitamin D and Calcium
    A.3.2Name or abbreviated title of the trial where available
    Sarcopenia Sub-Study
    A.4.1Sponsor's protocol code number0822-035
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLaboratoires Merck Sharp & Dhome-Chibret
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This is an exploratory sub-study of Protocol 018 (Eudract N°2007-002693-66) to identify biomarkers of physical function. This biomarker sub-study will use an ongoing clinical study (Protocol 018) for osteoporosis as a starting point for identification of molecular biomarkers in circulating blood for patient identification and sarcopenia progression. Patients recruited in Protocol 018 are women 65 years of age or older with osteoporosis and either 0 or 1 prior vertebral fracture.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031283
    E.1.2Term Osteoporosis fracture
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1A) To evaluate the phenotypic distribution of aLBM, SPPB, and gait speed in the study population. Specifically to determine if, at baseline, measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution.

    (1B) To identify biomarkers of sarcopenia by evaluating low aLBM, low SPPB, and low gait speed, separately and in combination, by examining DNA and RNA in circulating blood.

    (2A) To determine if there is a measurable change in aLBM, SPPB, and gait speed over time within the duration of the study. Specifically to determine if the rate-of-change in the measured traits (aLBM, SPPB and/or gait speed) form an appropriate distribution.

    (2B) To identify biomarkers of rate-of-change (fast vs slow) of aLBM, SPPB, and gait speed, separately or in combination, by examining DNA and RNA in circulating blood.
    E.2.2Secondary objectives of the trial
    Exploratory Objectives:

    (1) To perform multiple and partial correlation analyses to estimate the relationship among the following variables: longitudinal changes in appendicular lean body mass, measured by total body DXA, longitudinal changes in the SPPB score, longitudinal changes in gait speed, and longitudinal changes in the chair stand test.

    (2) To estimate the relationship between baseline incident mobility-disability (defined as self-reported difficulty with either walking 400 meters or climbing 10 steps without resting) and baseline (a) aLBM; (b) SPPB score; (c) gait speed.

    (3) To estimate the relationship between incident mobility-disability in years 2-4 (defined as new-onset of self-reported difficulty with either walking 400 meters or climbing 10 steps without resting) and decline in (a) aLBM; (b) SPPB score; (c) gait speed from baseline to 1 year.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is randomized and actively participating (on treatment) in Protocol 018. If the patient is discontinued from Protocol 018 then she can no longer participate in this sub-study.

    2. Patient is willing to participate in the sub-study as indicated by signing the informed consent form for this sub-study. The consent form for this sub-study includes general consent and consent for genetics and RNA testing.
    E.4Principal exclusion criteria
    1. Active conditions that limit general physical strength and function, particularly musculoskeletal in the lower extremities, such as:

    • Rheumatoid arthritis, polymyalgia rheumatica, polymyositis, Cushing’s syndrome
    • Neuromuscular diseases (i.e. stroke, multiple sclerosis)
    • Major surgery in the lower extremities in the past 2 months

    2. Patient has New York Heart Association (NYHA) Class III or IV congestive heart failure
    E.5 End points
    E.5.1Primary end point(s)
    Normalized clinical endpoint measurements, such as aLBM changes from baseline, will be directly correlated with mRNA expression levels in an effort to identify gene signatures whose regulations are associated with slow and fast progression of sarcopenia, thus discriminating patients who progress slowly from patients who progress fast with assumption that these clinical endpoint measurements would have two discernible distributions. Since no criteria have yet been established for defining the 'fast' and 'slow', an iterative partial least discriminant analysis developed by the Sponsor will be applied to selected clinical endpoint and mRNA expression data by randomly dividing the data into training and testing sets with a series of pre-defined cutoffs on selected clinical endpoint measurements. Data specific optimal cutoffs for this study will be determined by minimizing the prediction error and balancing between sensitivity and specificity. Pearson correlation coefficients will be calculated for each gene and signatures will then be ranked according to significance of correlations and absolute correlation coefficients. With total of 800 or more samples, it is estimated that the magnitude of correlation needs to be ≥ 0.6 to reach a FDR of 10% for 100 signature genes while testing among 10,000 pre-filtered genes.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The exact timepoint for the final visit (i.e. end of study) depends on the accumulation of a sufficient number of fracture events in Protocol 018. It is anticipated that Protocol 018 will end ~3 years after the end of enrollment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 2000
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The treatment plan for this sub-study is the same as for Protocol 018. Patients in Protocol 018 are randomized (1:1) to receive 50 mg odanacatib (MK-0822) or matching placebo once weekly. Additional drug will not be provided for this sub-study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-10-18
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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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