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    Summary
    EudraCT Number:2005-001511-22
    Sponsor's Protocol Code Number:004-30
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-08
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-001511-22
    A.3Full title of the trial
    A 5-Year Open Label Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in the Treatment of Postmenopausal Women with Osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    Cat-K II b Osteoporosis Study
    A.4.1Sponsor's protocol code number004-30
    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 Sharp & Dohme Corp.
    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.3.10 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
    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 14.1
    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 estimate the change from baseline (randomization in Protocol 004-02) in BMD at the lumbar spine at Years 8 and 10 with 50 mg of odanacatib once weekly in postmenopausal osteoporotic women previously treated for up to 5 years with odanacatib once weekly (in Protocols 004-02, 004-11, and 004-22).
    2) To assess the safety of treatment with odanacatib 50 mg once weekly for up to 10 years.
    E.2.2Secondary objectives of the trial
    1)To estimate change from baseline (randomization in Protocol 004-02) in BMD at the total hip, femoral neck, hip trochanter, and one-third distal radius with odanacatib 50 mg once weekly.
    2) To estimate change from baseline (randomization in Protocol 004-02) on biochemical indices of bone resorption and biochemical indices of bone formation (serum bone-specific alkaline phosphatase [s-BSAP], serum N-terminal propeptide of Type 1 collagen [s-P1NP]) with odanacatib 50 mg once weekly.
    3) To estimate change from Month 60 in Protocol 004-22 in BMD at the lumbar spine, total hip, femoral neck, hip trochanter, and one-third distal radius with odanacatib 50 mg once weekly.
    4) To estimate change from Month 60 in Protocol 004-22 on biochemical indices of bone resorption (u-NTx, s-CTx, s TRAP 5b, s 1CTP) and biochemical indices of bone formation (s-BSAP, s-P1NP) with odanacatib 50 mg once weekly.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Patient has met all initial inclusion criteria and has not met any of the exclusion criteria of Protocol 004-22. Note: There is no specific BMD T-score required for eligibility in this extension study at Visit 27 (Month 60) or at Visit 27E. Patients who meet excessive bone loss criteria at Visit 27 should be discontinued (see Section 3.2.3.6 for details).
    2) Patient has participated in and completed 60 months of treatment in Protocols 004-02, 004-11, and 004-22 (to be determined at Visit 27/Month 60).
    3) Patient is in generally good health, based on medical history, physical examination, and laboratory evaluation.
    E.4Principal exclusion criteria
    A patient may not enter the extension study if:
    1) Patient has withdrawn from Protocol 004-22 for any reason prior to completing 60 months of treatment.
    2) Patient experienced a hip, spine, or other fragility fracture during the previous studies (004-02, 004-11 and 004-22) and would prefer to take other osteoporosis therapy (bisphosphonates or PTH) for which she is eligible.
    Note: A fragility fracture is defined as a vertebral or non-vertebral fracture, excluding fingers, toes, or skull, that occurs when a person falls from a standing height or less, or a fracture sustained without falling, such as a vertebral fracture following coughing; these fractures indicate reduced bone strength, as normal-strength bone should be able to withstand this degree of load.
    3) Patient was diagnosed with primary parathyroid disease during the previous studies (004-02, 004-11 and 004-22) and has an elevated PTH or a serum calcium level greater than the upper limit of normal range.
    4) Patient has hypocalcemia as defined as serum calcium <8.5 mg/dL, when corrected for albumin, or evidence of secondary hyperparathyroidism.
    5) Patient has significant clinical or laboratory abnormalities at the baseline of this extension study (Visit 27/Month 60) that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient (for example, patients who are non-ambulatory should be excluded for this reason).
    6) Patient has cancer or had a diagnosis of any malignancy during the previous studies (004-02, 004-11 and 004-22), except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
    7) Patient is taking Vitamin A (excluding beta carotene) >10,000 IU daily or
    Vitamin D >5,000 IU daily.
    8) Patient has received treatment that may have an effect on bone, including, but not limited to (refer to Appendix 6.6):
    a) Current use of chemotherapy or heparin
    b) Protease inhibitors for HIV treatment at any time
    c) Patient is taking anti-seizure medication, and indices of calcium metabolism are not within normal limits (Note: if serum calcium is within normal limits, the patient may enroll based on this criterion)
    9) Current use of systemically administered azole antifungals (for example, systemic ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole) and other strong CYP3A4 inhibitors, such as clarithromycin and telithromycin (note: azithromycin is permitted).
    10) Patient is currently treated with strong CYP3A4 inducers (e.g., rifampin [rifampicin], phenobarbital, barbiturates, carbamazepine, phenytoin, St. John's wort, nevirapine, efavirenz, and etravirine).
    11) Patient is, in the opinion of the investigator, mentally or legally incapacitated such that informed consent cannot be obtained or the patient cannot read or comprehend the written material.
    12) Patient has participated in an investigational drug study other than Protocol 004-22 within the past 30 days.
    13) Patient is currently a user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse or dependence.
    14) Patient demonstrates noncompliance in following the procedures required in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the percent change from baseline in lumbar spine BMD
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    The date the last subject completes the final visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    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 years10
    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) Yes
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 90
    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 Decision2005-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-20
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