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    Summary
    EudraCT Number:2014-002587-33
    Sponsor's Protocol Code Number:MK-0822-018
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-12-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-002587-33
    A.3Full title of the trial
    An Open-Label 5-Year 2nd Extension to: 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 Postmenopausal Women Treated With Vitamin D and Calcium
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension to the Odanacatib Fracture Trial (PN018)
    A.3.2Name or abbreviated title of the trial where available
    Open-Label Extension to the Odanacatib Fracture Trial (PN018)
    A.4.1Sponsor's protocol code numberMK-0822-018
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 organisationMerck Sharp & Dhome Corp.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive, P.O Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889100
    B.5.3.4CountryUnited States
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOdanacatib
    D.3.2Product code MK-0822
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOdanacatib
    D.3.9.1CAS number 603139-19-1
    D.3.9.2Current sponsor codeMK-0822
    D.3.9.3Other descriptive nameODANACATIB
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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
    osteoporosis
    E.1.1.1Medical condition in easily understood language
    endocrinology
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    (1) to assess long-term changes from baseline in total hip bone mineral density (BMD) after 10 years of treatment with odanacatib 50 mg once-weekly in postmenopausal osteoporotic women previously treated with once-weekly odanacatib for at least 5 years
    (2) to assess safety and tolerability of long-term treatment with odanacatib 50 mg once-weekly.
    E.2.2Secondary objectives of the trial
    In postmenopausal women with osteoporosis previously treated with odanacatib 50 mg once-weekly for at least 5 years:
    (1) To assess long-term changes from baseline in bone mineral density (BMD) of lumbar spine, femoral neck (top of thigh), and trochanter (thigh bone) after 10 years of odanacatib treatment
    (2) To determine the incidence of morphometrically assessed vertebral fractures during 10 years of odanacatib treatment. Morphometrically assessed fractures are typically crushed vertebrae which are seen on spine X−ray but which generally do not cause any symptoms.
    (3) To determine the incidence of all clinical fractures during 10 years of odanacatib treatment. In postmenopausal women with osteoporosis previously treated with placebo for at least 5 years and then switched to open-label odanacatib 50 mg once-weekly:
    (4) To assess changes from baseline in BMD of lumbar spine, total hip, femoral neck, and trochanter during 5 years of odanacatib treatment
    (5) To determine the inc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have met all initial inclusion criteria and have not met any of the exclusion or
    discontinuation criteria of either the base or 1st extension studies.
    2. Be an active participant and have successfully completed the 1st extension study on study medication. (Note: An interruption of approximately 12 weeks from the end of 1st extension study to the beginning of 2nd extension study is permissible).
    3. Be assessed by the investigator as having had appropriate compliance during the base and 1st extension studies.
    4. Have at least one hip (e.g., contains no hardware from orthopedic procedures) AND
    suitable spinal anatomy that is evaluable by DXA.
    5. Understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agree to participate by providing informed consent.
    6. Be able to read, understand and complete questionnaires and diaries.
    7. Be in generally good health, based on medical history, physical examination, and
    laboratory evaluation.
    E.4Principal exclusion criteria
    The subject must be excluded from participating in the trial if the subject:
    1. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
    2. Is receiving treatment as follows:
    1) Current use of osteoporosis therapy including: bisphosphonates, PTH, strontium, systemic estrogen + progestin, raloxifene or other SERM, RANK ligand inhibitor, or sub-cutaneous calcitonin. (Note: use of intranasal calcitonin is permitted.)
    2) Subject is planning to initiate or is currently using long-term therapy (6 weeks
    or longer) with any CYP3A4 inducers (see Appendix 12.5 for examples).
    3. Is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the subject cannot read or comprehend the
    written material.
    4. Has participated in an investigational drug study other than the base study or 1st extension study within the past 30 days.
    5. Is currently a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in total hip bone mineral density (BMD) up to the end of the extension study
    E.5.1.1Timepoint(s) of evaluation of this end point
    At end of study (2019)
    E.5.2Secondary end point(s)
    Percent change from baseline in lumbar spine, femoral neck and trochanter (parts of the hip and thigh) bone mineral density (BMD) up to the end of the extension;
    Percent change from start of open-label (Year 6) in lumbar spine, total hip, femoral neck and trochanter BMD up to the end of the extension study;
    Time to first morphometric fracture (fracture detected by and X-ray, rather than by symptoms);
    Time to first clinical fracture (vertebral and non-vertebral).Vertebral fractures are fractures of the spine whereas non-vertebral fractures are non-spine fractures, For the purposes of this study, non-vertebral fractures exclude fractures of the fingers, toes, face, and skull.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At end of study (2019)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA143
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Denmark
    Dominican Republic
    Estonia
    France
    Germany
    Guatemala
    Hong Kong
    India
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lebanon
    Lithuania
    Mexico
    New Zealand
    Norway
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    South Africa
    Spain
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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 end of study visit for the 2nd extension should take place 5 years after the subject enrolled into the 2nd extension (i.e., if the subject is enrolled into the 2nd extension in November 2014, her end of study visit is expected to take place in November 2019).
    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 months2
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5000
    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 state780
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2350
    F.4.2.2In the whole clinical trial 5000
    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)
    All patients in this study are receiving active study drug MK0822. If MK0822 has a licence at the end of the study period patients may be able to continue receiving the study medication, however this will depend on study results.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-22
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-02-01
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