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    Summary
    EudraCT Number:2007-002693-66
    Sponsor's Protocol Code Number:0822-018
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-09-21
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2007-002693-66
    A.3Full title of the trial
    A Phase III Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of 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
    Study in Adult Patients to Reduce the Risk of Fracture in Osteoporotic Postmenopausal Women
    A.4.1Sponsor's protocol code number0822-018
    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 supportMerck Sharp & Dohme Corp., a Subsidiary of Merck and Co.,
    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 s.r.o.
    B.5.2Functional name of contact pointClinical Research Director
    B.5.3 Address:
    B.5.3.1Street AddressEvropska 2588/33a
    B.5.3.2Town/ cityPrague 6
    B.5.3.3Post code160 00
    B.5.3.4CountryCzech Republic
    B.5.4Telephone number+420233 010 281
    B.5.5Fax number+420233 010 140
    B.5.6E-mailjirina.nedvedova@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; Chemical name: N1-(1-cyanocyclopropyl)-4-fluoro-N2-{(1S)-2,2,2-trifluoro-1-[4’-(methylsulfo
    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/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) 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 Information not present in EudraCT
    D.IMP: 2
    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 namecholecalciferol (Vitamin D3)
    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 INNcholecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.3Other descriptive nameVitamin D3
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2800
    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
    E.1.1.1Medical condition in easily understood language
    Postmenopausal Osteoporosis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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
    To assess the effect of treatment with MK-0822 50 mg once weekly on the risk of morphometrically assessed vertebral fractures compared to placebo.

    To assess the effect of treatment with MK-0822 on the risk of hip fractures compared to placebo.

    To assess the effect of treatment with MK-0822 on the risk of clinical non-vertebral fractures compared to placebo. (Note: for the purposes of this study, non-vertebral fractures exclude fractures of the fingers, toes, face, and skull.)
    E.2.2Secondary objectives of the trial
    To assess the effect of treatment with MK-0822 50 mg once weekly:
    - on the risk of clinical vertebral fractures compared to placebo.
    - on height compared to placebo.
    - on the lumbar spine, total hip, femoral neck, trochanter and distal forearm BMD compared to placebo.
    - on the safety and tolerability of treatment.
    - on biochemical indices of bone resorption (serum C-Telopeptides of Type 1 collagen [s-CTX] and urine N-Telopeptides of Type 1 collagen [u-NTX]) compared to placebo
    - on biochemical indices of bone formation (serum bone-specific alkaline phosphatase [BSAP] and serum N-Terminal Propeptides of Type I collagen (s-P1NP) compared to placebo.
    - on qualitative histomorphometry of transilial bone biopsy specimens compared to placebo.
    - on decreasing of biochemical indices of bone resorption (s-CTx and u-UNTx) compared to placebo
    - on lumbar spine, total hip, femoral neck, and hip trochanter BMD comparet to placebo, in patients who are bisphophonate-intolerant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is a woman and is ≥ 65 years of age on the day of Randomization.
    2. Patient meets one of the following:
    a) Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score ≤-1.5 at either the total hip or femoral neck site, BMD T-score ≥-4.0 at both sites, and has one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR-
    b) Patient is a candidate for osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score ≤-2.5 at either the total hip or femoral neck site, BMD T-score ≥-4.0 at both sites, and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR -
    c) Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), has BMD T-score ≤-1.5 at either the total hip or femoral neck site, and has at least one prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%). – OR-
    d) Patient is not a suitable candidate for, or has declined osteoporosis therapy (bisphosphonates, strontium, or PTH), and has a BMD T-score ≤-2.5 at either the total hip or femoral neck site and does not have a prior vertebral fracture (defined as anterior, mid or posterior height loss of >20%).
    3. The patient has at least one hip that is evaluable by DXA (e.g., contains no hardware from orthopedic procedures).
    4. Patient has been postmenopausal for at least 5 years, defined as no menses for at least 5 years OR at least 5 years status post bilateral oophorectomy
    E.4Principal exclusion criteria
    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 , and she is a suitable candidate for osteoporosis therapy (i.e. bisphosphonates, strontium, or PTH).
    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.
    6) Patient has active parathyroid disease.
    7) Patient has a daily calcium intake of < 1200 mg and is unwillig to take study-prescribed supplements, such that her daily calcium intake is approximately 1200 mg.
    E.5 End points
    E.5.1Primary end point(s)
    Morphometric fractures, hip fractures, and clinical non-vertebral fractures.
    E.5.1.1Timepoint(s) of evaluation of this end point
    event-driven
    E.5.2Secondary end point(s)
    To assess the effect of treatment with odanacatib 50 mg once weekly on the risk of clinical vertebral fractures, on height and on the lumbar spine, total hip, femoral neck, trochanter and distal forearm BMD
    compared to placebo compared to placebo. To assess the safety and tolerability of treatment with odanacatib 50 mg once weekly compared to placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    event-driven
    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 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.8.2.4Number of treatment arms in the trial2
    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 concerned9
    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 years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    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 Decision2007-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-24
    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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