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    Summary
    EudraCT Number:2007-002693-66
    Sponsor's Protocol Code Number:0822-018
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-10-09
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-002693-66
    A.3Full title of the trial
    First Extension (018-06(PL_3)): A Blinded Extension to 5 Years for: 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

    Second Extension (018-20(PL_1)): A 2nd Open-Label Extension for 5 Years to: The Placebo-Controlled 1st Extension to a 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

    Second Extension (018-21(PL_2)): 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.4.1Sponsor's protocol code number0822-018
    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 SponsorMerck Sharpe & 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 organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal Osteoporosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    First Extension
    To assess the effect of treatment up to 5 years with odanacatib on the risk of morphometrically assessed vertebral fractures compared to placebo. To assess the effect of treatment up to 5 years with odanacatib on the risk of clinical hip fractures compared to placebo. To assess the effect of treatment up to 5 years with odanacatib on the risk of non-vertebral clinical fractures compared to placebo. To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo.

    Second extension:
    To assess long-term changes from baseline in total hip BMD during 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 (cumulative of base study and 1st extension study, i.e randomized to odanacatib during the base study
    To assess safety and tolerability of long-term treatment with odanacatib 50 mg once-weekly.
    E.2.2Secondary objectives of the trial
    First Extension
    To assess the effect of treatment up to 5 years with odanacatib 50 mg once weekly on the lumbar spine, total hip, femoral neck, and trochanter BMD compared to placebo.
    To assess the effect of treatment up to 5 years with odanacatib on the risk of all clinical (both non-vertebral and vertebral) fractures compared to placebo.

    Second extension
    To assess long-term changes from baseline in BMD of lumbar spine, femoral neck, and trochanter during 10 years of treatment with odanacatib 50 mg once-weekly.
    To determine the incidence of morphometrically assessed vertebral fractures during 10 years of treatment with odanacatib 50 mg once-weekly.
    To determine the incidence of all clinical (both non-vertebral and vertebral) fractures during 10 years of treatment with odanacatib 50 mg once-weekly.
    To assess changes from baseline in BMD of lumbar spine, total hip, femoral neck, and trochanter during 5 years of treatment with odanacatib 50 mg onceweekly.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    First Extension
    Note that patients inappropriately randomized into the trial (i.e., those who do not meet entry criteria) may be discontinued from the study at the discretion of the SPONSOR.

    1) Patient completed the base study on blinded study therapy PN018 (Note that an interruption up to 6 weeks at end of the base study is acceptable).
    2) Patient has at least one hip (e.g. contains no hardware from orthopedic procedures) and suitable spinal anatomy that is evaluable by DXA.
    3) Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by providing informed consent.
    4) Patient/subject is able to read, understand and complete questionnaires and diaries. Note: If a patient who understands the purpose and use of the diary cards and study questionnaires is unable to complete these without assistance (e.g. due to visual
    problems, difficulty writing due to arthritis, inability to read, etc.), a family member or care-giver may assist or may complete the diary card on her behalf.

    Second Extension
    NOTE: Subjects inappropriately randomized into the trial (i.e., those who do not meet entry
    criteria) may be discontinued from the study at the discretion of the SPONSOR.
    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 that an interruption about 12 weeks at end of the extension study is acceptable).
    3. Have demonstrated compliance in following the procedures required during the base and/or 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 agrees to participate by providing informed consent.
    6. Be able to read, understand and complete questionnaires and diaries.
    7. Subject is in generally good health, based on medical history, physical examination, and laboratory evaluation.
    E.4Principal exclusion criteria
    Base study
    1) Patient has chosen treatment with oral bisphosphonates or other agents demonstrated to reduce the risk of hip fracture.
    2) Patient has had a prior hip fracture.
    3) Patient experienced a clinical fragility fracture (including a clinical vertebral fracture) within 24 months. (Note: Finger, toe, and skull fractures should not be considered with regard to this exclusion criterion.)
    4) Patient has had more than 1 prior vertebral fracture, as defined in Inclusion Criterion 1 above, and she is a suitable candidate for osteoporosis therapy (i.e., bisphosphonates, strontium, or PTH).
    5) Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.

    First Extension
    Note that patients inappropriately randomized into the trial (i.e., those who do not meet entry criteria) may be discontinued from the study at the discretion of the SPONSOR.
    1) Patient 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 patient’s participation for the full duration of the study, such that it is not in the best
    interest of the patient to participate.
    2) Patient met excessive bone loss criteria as defined in the base study.
    3) Patient met any of the discontinuation rules as defined in the base study PN018.
    4) Patient is receiving treatment with:
    a. Current use of osteoporosis therapy including: bisphosphonates, PTH, strontium ranelate, systemic estrogen + progestin, raloxifene or other SERM, RANK ligand inhibitor, or sub-cutaneous calcitonin. (Note: use of intranasal calcitonin is permitted.)
    b. Current use of long-term therapy (6 months) with any strong CYP3A4 inducers (e.g. rifampin, carbamazepine, phenytoin, St. John’s wort).

    Second extension
    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 with:
    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 strong 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)
    First Extension
    The primary focus of this study will be on morphometic vertebral fractures. Lateral thoracic and lumbar spine radiographs will be obtained for each patient at baseline of the core study, Month 6, Month 12, and yearly thereafter until the end of the 5-year doubleblind extension study. The primary endpoint will be the first morphometrically assessed vertebral fracture per patient determined from these radiographs, analyzed as intervalcensored
    survival data. All available x-ray data will be included in the analyses and time windows will be defined in a separate document to define timing, extending those of the core study.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    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 concerned20
    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 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 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
    This is an event-driven trial, which will end when the required number of fractures to test the hypotheses have occurred
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years13
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years13
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 state1500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6650
    F.4.2.2In the whole clinical trial 16300
    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)
    None.
    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 Decision2007-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-13
    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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    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
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