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    Summary
    EudraCT Number:2007-002693-66
    Sponsor's Protocol Code Number:0822-018
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-002693-66
    A.3Full title of the trial
    1st extension (MK-0822-018-06, issue date 19-Jun-2013)

    A Blinded Extension to 5 Years of 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

    2nd extension (MK-0822-018-21, issue date 15-Jul-2014)

    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
    1st extension: Treatment of osteoporosis in postmenopausal women to prevent fractures - extension of treatment period to 5 years

    2nd extension: Open-label treatment of osteoporosis in postmenopausal women to prevent fractures: 2nd extension of treatment period for 5 years.
    A.3.2Name or abbreviated title of the trial where available
    Long-term Odanacatib Fracture Trial (LOFT)
    A.4.1Sponsor's protocol code number0822-018
    A.5.4Other Identifiers
    Name:1st extension: MK-0822-018-06Number:2nd extension: MK-0822-018-21
    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 supportMerck & Co.,Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.5.2Functional name of contact pointSui W. Yan
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive P.O Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number001732594 2615
    B.5.5Fax number001732594 7700
    B.5.6E-mailsui_yan@merck.com
    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 nameMK-0822 - Odanacatib
    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.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postmenopausal Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Bone disease that leads to an increased risk of fracture in postmenopausal women.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    1st extension (MK0822-018-06):
    To assess the effect of treatment up to 5 years with odanacatib compared to placebo on the risk of morphometrically assessed vertebral fractures and of clinical hip fractures.
    To assess the effect of treatment up to 5 years with odanacatib on the risk of non-vertebral clinical fractures compared to placebo. (Note: nonvertebral fractures excl. fractures of the fingers, toes, face, and skull.)
    To assess safety and tolerability of treatment up to 5 years with odanacatib 50 mg once weekly compared to placebo.

    2nd extension (MK0822-018-21):
    To assess change from baseline in total hip BMD after 10 years of treatment and to assess safety and tolerability of long-term treatment in postmenopausal women with osteoporosis randomized to odanacatib 50 mg once-weekly in the base study and continuing on odanacatib during base and both extension periods.
    E.2.2Secondary objectives of the trial
    1st extension (MK0822-018-06):
    - To assess the effect of treatment up to 5 years with odanacatib on the risk of clinical vertrebral fractures 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 vertrebral) fractures compared to placebo.
    - 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.

    2nd extension (MK0822-018-21):
    In postmenopausal women randomized to odanacatib 50 mg/once weekly, and continuing on MK0822 during base and both extension period, after 10 years of treatment:
    - To assess change from baseline in BMD of lumbar spine, femoral neck, and trochanter.
    - To determine the incidence of morphometrically assessed vertrebral fractures
    - To determine the incidence of all clinical fractures

    In postmenopausal women with osteoporosis previously treated with placebo for 5 years and switched to MK0822 at entry of the 2nd extension:
    - To assess changes from baseline (start of open-label treatment) in BMD of lumar spine, total hip, femoral neck and trochanter during 5 years of treatment with MK0822 50 mg/once weekly
    - To determine the incidence of morphometrically assessed vertrebral fractures during 5 years of treatment with Mk0822 50 mg/once weekly
    - To determine the incidence of all clinical fractures during 5 years of treatment with Mk0822 50 mg/once weekly.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1st extension (MK-0822-018-06):

    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.

    2nd extension (MK-0822-018-21):

    1.Have met all initial inclusion criteria and have not met any of the exclusion or discontinuation criteria of either the base or the 1st extension studies. (NOTE: there is no specific BMD T-score required for eligibility in this extension study. If a subject has met excessive bone loss criteria at her end of study visit for the 1st extension study, or the 2nd extension screening visit, she can continue into this 2nd extension).
    2. Be an active participant and have successfully completed the 1st extension study on study medication. (Note that an interruption of approximately 12 weeks from the end of the 1st extension study to the beginning of the 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 a least one hip (eg, 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 (a family member or care-giver may assist or may complete the diary on her behalf)
    7. Be in generally good health, based on medical history, physical examination, and laboratory evaluation.
    E.4Principal exclusion criteria
    1st extension (MK-0822-018-06):

    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 discontinuations rules as defined in the base study.
    4. Patient is receiving treatment with:
    -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.)
    -Current use of long-term therapy (>6 weeks) with any strong CYP3A4 inducers (e.g. rifampin (rifampicin), carbamazepine, phenytoin, St. John's wort).
    5. Patient has or has had evidence of a metabolic bone disorder other than osteoporosis.

    2nd extension (MK-0822-018-21):

    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 subject's participation for the full duration of the study, such that it is not in the full interest of the subject to participate.
    2. Is receiving treatment with:
    -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.)
    -Subject is planning to initiate or is currently using long-term therapy (6 months or longer) with any CYP3A4 inducers .
    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)
    1st extension (MK-0822-018-06):

    Time to first morphometric vertebral fracture.

    2nd extension (MK-0822-018-21):

    (In subjects randomized to odanacatib 50 mg OW in the base study and continuing on odanacatib in the extension):
    % change from baseline in total hip BMD at Year 10
    E.5.1.1Timepoint(s) of evaluation of this end point
    1st extension (MK-0822-018-06):
    After 5 years of treatment

    2nd extension (MK-0822-018-21):
    End of study.
    E.5.2Secondary end point(s)
    1st extension (MK-0822-018-06):

    Percent change from baseline in lumbar spine, femoral neck, total hip and trochanter BMD at the yearly endpoints.
    Time to first clinical adjudicated osteoporotic fracture and adjudicated non-vertebral fractures.

    2nd extension (MK-0822-018-21):
    (In subjects randomized to odanacatib 50 mg OW in the base study and continuing on odanacatib in the extension):
    - % change from baseline in total hip BMD at all other time points up to the end of the extension study
    - % change from baseline in lumbar spine, femoral neck and trochanter BMD at each time point up to the end of the extension study
    - time to first morphometric fracture
    - time to first clinical fracture (vertebral and non-vertebral)
    (In subjects randomized to placebo in the base study and continuing on odanacatib in the extension):
    - % 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
    - time to first clinical fracture (vertebral and non-vertebral)
    E.5.2.1Timepoint(s) of evaluation of this end point
    both extensions : Every year
    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 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 Yes
    E.8.1.2Open Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA91
    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
    Bulgaria
    Chile
    China
    Colombia
    Croatia
    Czech Republic
    Denmark
    Dominican Republic
    Estonia
    France
    Germany
    Guatemala
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Latvia
    Lithuania
    Mexico
    New Zealand
    Norway
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    United States
    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 base study began enrollment in September 2007; some of the subjects would have completed 5 years of blinded treatment and started open-label odanacatib in September 2012. Therefore, total duration of open-label treatment (open label portion of the 1st extension and the 2nd extension study) may be up to 7 years depening on when the subject enrolled in the base study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months3
    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 state12
    F.4.2 For a multinational trial
    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)
    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 Decision2008-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-13
    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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