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    Summary
    EudraCT Number:2005-001511-22
    Sponsor's Protocol Code Number:MK-0822004-11&004-21&004-30
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-07-14
    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 number2005-001511-22
    A.3Full title of the trial
    A 24-Month Extension to: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of MK-0822 (Cathepsin-K Inhibitor) in the Treatment of Postmenopausal Women with Osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    Cat-K 11b Osteoporosis Study
    A.4.1Sponsor's protocol code numberMK-0822004-11&004-21&004-30
    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., 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 nameL-001037536
    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.3.9.2Current sponsor codeL-001037536
    D.3.9.3Other descriptive nameMK-0822
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3, 10, 25, & 50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    For Base Study: To assess the effect of L-001037536 3 mg weekly, 10 mg weekly, 25 mg weekly, and 50 mg weekly on lumbar spine BMD compared to placebo over 12 months.

    For 24 Months Extension: To assess the time course of the resolution of effect on lumbar spine BMD during the 12 month extension following 24 months of treatment with MK 822 once weekly in postmenopausal women with osteoporosis.

    Extension to 36 months: To assess the resolution of effect at 36 months on lumbar spine BMD following 24 months of treatment with MK-0822 once weekly in post-menopausal women with osteoporosis.

    Extension to 5 years:To estimate BMD differences at the lumbar spine during years 3-5 in post-menopausal osteoporotic women

    5 year open-label extension: 1) To estimate the change from baseline on lumbar spine BMD at years 8 & 10 with MK-0822 in postmenopausal osteoporotic women 2) to assess the safety of treatment with MK-0822 50 mg once weekly for up to 10 years.
    E.2.2Secondary objectives of the trial
    For base and 24 Month Extension: To assess the effect of 3, 10, 25, and 50 mg- on (1) total hip, femoral neck, trochanter, total body, and distal forearm BMD (2) biochemical indices of bone resorption (u-NTx, s-CTx, u-DPyr) and bone formation (s-BSAP, s-P1NP) (3) indices of calcium and mineral homeostasis (s-calcium, s-phosphorus, s PTH, s-1,25-dihydroxyvitamin D, 24 h urine calcium) (4) safety and tolerability (5) Iidentify the optimal dose.
    Up to 5 years: 1) to assess long-term safety 2) in patients previously taking 10, 25, or 50 mg for 2 years, to assess the effect at month 36 of treatment with 50 mg and without treatment on all markers stated above for the base study.
    5 year open label extension: to estimate the change with 50 mg from baseline and from month 60 1) in BMD at the lumbar spine, total hip, femoral neck, hip trochanter, and one-third distal radius ( 2) on biochemical indices of bone resportion and bone formation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Postmenopausal female (> 5 years) between 45-85 years old.

    T-score at the hip (femoral neck, trochanter or total) or lumbar spine <-2.0, but not < -3.5.

    The patient has spinal anatomy suitable for dual-energy x-ray absorptiometry (DXA) of the lumbar spine with no evidence of vertebral fractures in at least 3 vertebrae in the L1 to L4 region on baseline spine films. (Significant scoliosis, bony trauma, degenerative joint disease, and sequelae of orthopedic procedures that result in anatomy that is unsuitable for accurate bone densitometry must be absent from the lumbar spine.)
    The patient has a 25-hydroxyvitamin D level ≥15 ng/dL. If the level is ≥ 9 and < 15 ng/dL, she may enter if her alkaline phosphatase and PTH levels are normal.
    The patient has no evidence of a metabolic bone disorder other than osteopenia or osteoporosis.
    The patient understands the procedures of the study, has been informed of potential alternative treatments for osteoporosis, and is willing to give written informed consent for participation.
    The patient agrees not to use medications for the treatment of osteoporosis (except as provided through this study) for the duration of her participation in the trial.
    Extension phase: Patient has participated and completed 24 months of treatment in base study, is generally in good health based on medical history, physical examination and laboratory evaluation.
    extension phase: Patient has completed base study and is generally in good health based on medical history, physicial examination and laboratory examination.
    extension phase to 10 yrs: has completed 60 months of treatment in protocols 004-02, 044-11, and 044-22. met all initial inclusion criteria and not met any exclusion criteria.
    E.4Principal exclusion criteria
    Base study: The patient has a BMD T-score at the spine or hip (femoral neck, trochanter, or total) <-3.5.
    The patient has a history of prior hip, spine, or other fragility fracture since menopause (UNLESS the patient is unwilling to take, or is ineligible for, other osteoporosis therapy [bisphosphonates or PTH]).
    The patient has received any agents with action on bone including the following: a) anabolic steroids or glucocorticoids (≥ 5 mg/day prednisone or equivalent) for more than 2 weeks in the prior 6 months, b) bisphosphonates (any oral use within the past 6 months; ≥ 2 weeks use within the past 12 months; or > 2 months use at any time), or any I.V. bisphosphonates, c) cyclosporin for more than 2 weeks within the prior 6 months, d) fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks at any time, e) strontium (at any time) f) PTH within 12 months, g) current use of phenytoin, chemotherapy, or heparin, or h) use of growth hormone at any time.
    The patient has used estrogen ± progestin, raloxifene or other SERM, tamoxifen, tibolone, or an aromatase inhibitor within the prior 6 months or calcitonin within the prior 30 days. (Note: Vaginal estrogen creams used topically ≤ twice weekly will be permitted).
    The patient is currently taking Vitamin A (excluding beta carotene) > 10,000 IU daily or Vitamin D > 5,000 IU daily and not willing to discontinue this dose during the study.
    The patient has primary parathyroid disease with an elevated PTH or in conjunction with serum calcium greater than the upper limit of normal. (Note: patients with a history of primary hyperparathyroidism and with curative parathyroidectomy ≥ 2 years are not excluded).
    The patient has a TSH < 0.1 ng/dL.
    The patient has hypocalcemia as defined as serum calcium <8.5 ng/dL, when corrected for albumin, or evidence of secondary hyperparathyroidism.
    Patients with a) a history of marked baseline prolongation of QT/QTc interval (eg. repeated demonstration of a QTc interval >450), or b) additional risk factors for Torsades de Pointes (eg. heart failure, hypokalemia, family history of Long QT Syndrome), or c) concomitant use of medications that prolong the QT/QTc interval (eg. quinidine, procainamide, disopyramide, tricyclic antidepressants, phenothiazines, amiodarone or sotalol) will be excluded.
    The patient has significant clinical or laboratory abnormalities at the screening visit for the study that, in the opinion of the investigator, could complicate interpretation of the study results or pose additional risk to the patient.
    The patient has a significant, unexplained laboratory abnormality.
    The patient has cancer or had a diagnosis of any malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
    The 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.
    The patient has participated in an investigational drug study within the past 30 days.
    The patient is currently a user of any illicit drug and/or has a history of alcohol abuse.
    The patient demonstrates noncompliance in following the procedures required in the study.
    Extension phase to 3 years and to 5 years : Patient meets any of the above exclusion criteria at visit 13/ month 24 of the base study or visit 18/month 36. Patient has withdrawn from the base study for any reason prior to completing the first extension. Patient has experienced a hip, spine or other fragility fracture during the base study and would prefer to take other osteoporosis therapy.
    Patient has received treatment with an agent that may have an effect on bone, including:Current use of chemotherapy or heparin, Protease inhibitors for HIV treatment at any time, Patient is taking anti-seizure medication, and indices of calcium metabolism are not within normal limits (Note: if indices of calcium metabolism [serum calcium, serum 25-hydroxyvitamin D and serum PTH] are within normal limits, the patient may enroll based on this criterion) Current use of systemically administered azole antifungals (eg., ketoconazole, fluconazole, itraconazole, miconazole, posaconozole, ravuconazole, and voriconazole).
    Extension phase to 10 years: 1) Patient meets any of the above exclusion criteria for the base study and/or previous extension phases. 2) Patient was diagnosed with primary parathyroid disease during the previous studies. 3) Patient has cancer or had a diagnosis of any malignacny during the previous studies. 4) Current use of systemically administered azole antifungals and other strong CYP3A4 inhibitors, such as clarithromycin and telithromycin. 5) Patient is currently treated with strong CYP3A4 inducers (eg rifampin, phenobarbital, barbiturates, carbamazepine, phenytoin, St. Johns Wort, nevirapine, efavirenz and etravirine).
    E.5 End points
    E.5.1Primary end point(s)
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    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) 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.8.5The trial involves multiple Member States Yes
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 375
    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 Decision2005-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-01-20
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