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    Summary
    EudraCT Number:2013-005551-32
    Sponsor's Protocol Code Number:20110174
    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:2014-06-06
    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 number2013-005551-32
    A.3Full title of the trial
    A Multicenter, Randomized, Double blind, Placebo controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
    A.3.2Name or abbreviated title of the trial where available
    BRIDGE
    A.4.1Sponsor's protocol code number20110174
    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 SponsorAmgen, 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 supportAmgen Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportUCB, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (Europe) GmbH
    B.5.2Functional name of contact pointIHQ-Medical Info - Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, P.O Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfoInternational@amgen.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 nameromosozumab
    D.3.2Product code AMG 785
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNromosozumab
    D.3.9.2Current sponsor codeAMG 785
    D.3.9.4EV Substance CodeSUB31075
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    male osteoporosis
    E.1.1.1Medical condition in easily understood language
    male 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 18.1
    E.1.2Level PT
    E.1.2Classification code 10031282
    E.1.2Term Osteoporosis
    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 evaluate the effect of treatment with romosozumab for 12 months compared with placebo on percent changes in bone mineral density (BMD) at the lumbar spine as assessed by dual energy x ray absorptiometry (DXA) in men with osteoporosis.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of treatment with romosozumab for 12 months compared with placebo on the percent changes in DXA BMD at the total hip and femoral neck
    - To evaluate the effect of treatment with romosozumab for 6 months compared with placebo on the percent changes in DXA BMD at the lumbar spine, total hip, and femoral neck
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Bone biopsy sub-study to assess the effect of romosozumab compared
    with placebo on parameters of bone histology and histomorphometry
    E.3Principal inclusion criteria
    - Subject has provided informed consent prior to initiation of any study specific activities/procedures
    - Ambulatory male subjects ≥ 55 years to ≤ 90 years of age, at the time of enrollment
    - Increased risk of fracture, defined as:
     * BMD T-score ≤ -2.50 at the lumbar spine, total hip, or femoral neck, based on DXA scans
    OR
     * BMD T-score ≤ -1.50 at the lumbar spine, total hip, or femoral neck, based on DXA scans and a history of fragility nonvertebral fracture or vertebral facture (thoracic or lumbar)
    - Subject has at least 2 evaluable vertebrae in the L1 to L4 region, as assessed by the principal investigator or designee
    - Subject has at least 1 evaluable hip, as assessed by the principal investigator or designee
    E.4Principal exclusion criteria
    - BMD T-score ≤ -3.50 at the total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans
    - History of hip fracture
    - Oral bisphosphonates:
     * any dose received within 3 months prior to randomization
    * more than 1 month of cumulative use between 3 and 12 months prior to randomization
     * more than 3 years of cumulative use, unless last dose received ≥ 5 years prior to randomization
    - Intravenous (IV) bisphosphonates
     * Zoledronic acid:
    o any dose received within 3 years prior to randomization
    o more than 1 dose received within 5 years prior to randomization
     IV ibandronate, IV pamidronate, or IV alendronate:
    o any dose received within 12 months prior to randomization
    o more than 3 years of cumulative use, unless last dose received ≥ 5 years prior to randomization
    - Teriparatide or any parathyroid hormone (PTH) analogs:
     * any dose received within 3 months prior to randomization
     * more than 1 month of cumulative use between 3 and 12 months prior to randomization
    - Strontium ranelate, or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization
    - Denosumab or any cathepsin K inhibitor, such as odanacatib (MK-0822): any dose received within 18 months prior to randomization
    - Tibolone, cinacalcet, or calcitonin: any dose received within 3 months prior to randomization
    - Systemic glucocorticosteroids: ≥ 5 mg prednisone equivalent per day for more than 14 days within 3 months prior to randomization
    - Anabolic steroids: any use within 6 months prior to randomization. Testosterone is permitted providing treatment was not begun within the 6 months prior to randomization
    - Hormonal ablation therapy: more than 1 month of cumulative use within 6 months prior to randomization
    - History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia, and malabsorption syndrome
    - Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth (eg, as seen in conditions such as Paget’s disease, sclerosteosis, and osteopetrosis)
    - History of solid organ or bone marrow transplant
    - Vitamin D insufficiency (defined as 25 (OH) vitamin D levels < 20 ng/ml as determined by the central laboratory). Vitamin D repletion will be permitted and subjects may be rescreened
    - Current, uncontrolled hyper- or hypothyroidism, per subject report or chart review. Uncontrolled hyperthyroidism is defined as TSH and T4 outside the normal range. Uncontrolled hypothyroidism is defined as TSH > 10
    - Current, uncontrolled hyperparathyroidism or history of hypoparathyroidism, per subject report or chart review. Uncontrolled hyperparathyroidism is defined as:
    * PTH outside the normal range in subjects with concurrent hypercalcemia; or PTH values > 20% above the upper limit of normal (ULN) in normocalcemic subjects
    - Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory.
    - Subject previously has entered this study or has previously participated in a study with a sclerostin antibody product
    - Malignancy within the last 5 years, except non-melanoma skin cancers
    - Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory (electrophoresis results within 6 months of signing consent will be acceptable)
    - Currently receiving treatment in another investigational device or drug study
    - Other investigational procedures while participating in this study are excluded
    - Positive for hepatitis B, hepatitis C, chronic hepatitis C, and negative viral load while receiving treatment for hepatitis Cas assessed by the central laboratory
    - Positive results for human immunodeficiency virus (HIV), per subject report or chart review
    - Subject has known sensitivity to any of the products to be administered during dosing (calcium supplements, vitamin D products, or mammalian cell derived products)
    - Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator’s knowledge
    - History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in DXA BMD at the lumbar spine at month 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    month 12
    E.5.2Secondary end point(s)
    - Percent change from baseline in DXA BMD at the femoral neck and total hip at month 12
    - Percent change from baseline in DXA BMD at the lumbar spine, femoral neck, and total hip at month 6
    E.5.2.1Timepoint(s) of evaluation of this end point
    Months 6 and 12
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Bone biopsy sub-study to assess the effect of romosozumab compared with placebo on parameters of bone histology and histomorphometry
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Belgium
    Colombia
    Czech Republic
    Denmark
    Japan
    Mexico
    Poland
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days29
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 137
    F.4.2.2In the whole clinical trial 225
    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 Decision2014-07-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-20
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