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    Summary
    EudraCT Number:2011-003142-41
    Sponsor's Protocol Code Number:20110142
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-30
    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 ConcernedIreland - HPRA
    A.2EudraCT number2011-003142-41
    A.3Full title of the trial
    A Multicenter, International, Randomized, Double-blind,
    Alendronate-controlled Study to Determine the Efficacy and Safety of
    Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of Romosozumab Treatment Compared to Alendronate in Postmenopausal Women with Osteoporosis
    A.4.1Sponsor's protocol code number20110142
    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 AMG785
    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 codeAMG785
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number210
    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 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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name FOSAMAX
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp and Dohme Corp.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameFOSAMAX
    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.3.9.3Other descriptive nameALENDRONATE SODIUM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB25549
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 No
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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
    Osteoporosis
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 the overall study period (12-month double-blind alendronate [ALN]-controlled study period
    followed by the open-label ALN study period)
    • To assess the effect of romosozumab treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) in women with PMO
    • To assess the effect of romosozumab treatment for 12 months followed by ALN treatment compared with ALN treatment alone on the subject incidence of new vertebral fracture in women with PMO
    E.2.2Secondary objectives of the trial
    To assess the effect of romosozumab treatment for 12 months followed by ALN treatment compared with ALN treatment alone on:
    • Subject incidence of fractures (all fractures [nonvertebral fractures and new or worsening vertebral fractures], new or worsening vertebral fracture, nonvertebral fracture, major nonvertebral fracture [pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip], hip fracture, and multiple new or worsening vertebral fracture)
    • Percent changes in Dual energy X-ray Absorptiometry (DXA) bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck
    To assess the effect of romosozumab treatment for 12 months compared with ALN treatment on:
    • Subject incidence of fractures (clinical fracture [nonvertebral fracture and clinical vertebral fracture], new vertebral fracture, all fractures [nonvertebral fractures and new vertebral fractures])
    • 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
    Imaging and Pharmacokinetics (PK) / Bone Turnover Marker (BTM) / Biomarker Sub-study
    Objectives:
    For the 12-month double-blind ALN-controlled study period
    • To characterize the serum romosozumab concentration
    • To assess the effect of romosozumab treatment for 12 months compared with ALN treatment on:
    - Percent changes in bone formation markers Procollagen Type 1 N-telopeptide (P1NP), Bone Specific Alkaline Phosphatase (BSAP), and Osteocalcin (OC) and in bone resorption marker serum Type I collagen C-telopeptide (sCTX)
    - Percent changes in sclerostin and intact Parathyroid Hormone (iPTH)
    - Percent changes in integral (total) and trabecular volumetric BMD (vBMD) at the lumbar spine by Quantitative Computed Tomography (QCT)
    - Percent changes in lumbar spine strength as assessed by Finite Element Analysis (FEA)
    • To assess the effect of romosozumab treatment for 6 months compared with ALN treatment for 6 months on percent changes in DXA BMD at the lumbar spine, total hip, and femoral neck
    • To enable exploratory assessments of novel biomarkers through prospective collection of blood samples

    For the overall study period (12-month double-blind ALN-controlled study period followed by the open-label ALN study period)
    • To assess the effect of romosozumab treatment for 12 months followed by ALN treatment compared with ALN treatment alone on:
    - Percent changes in bone formation marker P1NP and bone resorption marker sCTX
    - Percent changes in sclerostin and iPTH
    - Percent changes in integral (total) and trabecular vBMD at the lumbar spine by QCT
    - Percent changes in lumbar spine strength as assessed by FEA
    • To assess the effect of romosozumab treatment for 12 months followed by ALN treatment for 6 months compared with ALN treatment alone on percent changes in DXA BMD at the lumbar spine, total hip, and femoral neck
    • To enable exploratory assessments of novel biomarkers through prospective collection of blood samples
    E.3Principal inclusion criteria
    4.1.1 Ambulatory postmenopausal women, age ≥ 55 to ≤ 90 years at randomization. Postmenopausal status is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening.
    4.1.2 Subject meets at least one of the following BMD and fracture criteria
    BMD T-score ≤ -2.50 at the total hip or femoral neck AND EITHER at least one moderate (SQ2) or severe (SQ3) vertebral fracture OR at least 2 mild (SQ1) vertebral fractures
    or
    BMD T-score ≤ -2.00 at the total hip or femoral neck AND EITHER at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR a fracture of the proximal femur that occurred within 3 to 24 months prior to randomization
    BMD T-scores at the time of screening will be assessed by the central imaging vendor based on DXA scans and using data for Caucasian women from the National Health and Nutritional Examination Survey
    (NHANES) 1998.
    Vertebral fractures at the time of screening will be assessed by the central imaging vendor based on lateral spine x-rays.
    History of proximal femur fracture will be assessed by the principal investigator based on discharge summary, radiology report, or comparable documentation of type and date of fracture.
    4.1.3 At least one hip is evaluable by DXA, as assessed by the principal investigator
    4.1.4 Subject has provided informed consent
    E.4Principal exclusion criteria
    -Strontium ranelate,or fluoride (for osteoporosis): more than 1 month of cumulative use within 5 years prior to randomization
    -(IV) bisphosphonates
    -Zoledronic acid:
    -any dose received within 3 years prior to randomization
    -more than 1 dose received within 5 years prior to randomization
    -IV ibandronate or IV pamidronate:
    -any dose received within 12 months prior to randomization
    -more than 3 years of cumulative use, unless last dose received ≥ 5 years prior to randomization
    -Oral bisphosphonates:
    • More than 3 years of cumulative use, unless last dose received ≥ 5 years prior to randomization
    • Any dose received within 3 months prior to randomization
    • More than 1 month of cumulative use between 3 and 12 months prior to randomization
    -Denosumab or any cathepsin K inhibitor,such as odanacatib:any dose received within 18 months prior to randomization
    -Teriparatide or any 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
    -Systemic oral or transdermal estrogen or SERMs:more than 1 month of cumulative use within 6 months prior to randomization
    -Hormonal ablation therapy: more than 1 month of cumulative use within 6 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
    -History of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as sclerosteosis, Paget's disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
    -History of solid organ or bone marrow transplants
    -Vitamin D insufficiency, vitamin D levels < 20 ng/mL as assessed by the central laboratory.
    -Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range, as assessed by the central laboratory.
    Serum calcium levels may be retested once in case of an elevated serum calcium level within 1.1x the upper limit of normal as assessed by the central laboratory.
    -Current, uncontrolled hyper- or hypothyroidism, defined as thyroidstimulating hormone outside of the normal range, per subject report or chart review
    -Current, uncontrolled hyper- or hypoparathyroidism, defined as PTH outside the normal range, per subject report or chart review
    -Possible diagnosis of multiple myeloma or related lymphoproliferative disorder, as assessed by serum protein electrophoresis performed by the local laboratory
    -Exclusion criteria related to contraindications or possible signs ofintolerance to ALN; contraindications and potential signs of intolerance for ALN therapy include:
    •Hypocalcemia
    • Abnormalities of the esophagus, which delay esophageal emptying
    such as stricture or achalasia
    • Inability to stand or sit upright for at least 30 minutes
    • Hypersensitivity to ALN or other constituents of ALN tablets
    • Pregnancy and lactation
    • Other contraindications to ALN based on the country-specific product insert applicable to the specific study center
    • Significantly impaired renal function.
    -General
    • Subject is currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
    • Subject has previously entered this study or has previously participated in a study with a sclerostin antibody product
    • Other investigational procedures are excluded
    • Malignancy within the last 5 years except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
    • Subject has known sensitivity to any of the products or components to be administered (calcium supplements, vitamin D products, or mammalian cell derived products)
    • Subject is pregnant or is planning to become pregnant within 3 months after the last dose of IP
    • Subject will not be available for protocol-required study visits or procedures, to the best of the subject and investigator's knowledge
    • Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures
    • Subject is known to have human immunodeficiency virus, hepatitis C virus, or hepatitis B infection
    • Subject has any condition or illness, which in the opinion of the Investigator might interfere with the evaluation of the safety of the study product or may otherwise compromise the safety of the subject
    • Subject with reported history of hearing loss associated with cranial nerve VIII compression due to excessive bone growth
    E.5 End points
    E.5.1Primary end point(s)
    During the overall study period (12-month double-blind ALN-controlled study period followed by the open label ALN study period)
    • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) at primary analysis
    • Subject incidence of new vertebral fracture through Month 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    E.5.2Secondary end point(s)
    During the overall study period (12-month double-blind ALN-controlled study period followed by the open-label ALN study period)
    • Subject incidence of nonvertebral fracture at primary analysis
    • Subject incidence of all fractures (nonvertebral fracture and new or worsening vertebral fracture) at primary analysis
    • Subject incidence of new or worsening vertebral fracture through Month 24
    • Subject incidence of major nonvertebral fracture (pelvis, distal femur, proximal tibia, ribs, proximal humerus, forearm, and hip) at primary analysis
    • Subject incidence of hip fracture at primary analysis
    • Subject incidence of multiple new or worsening vertebral fractures through Month 24
    • Percent change from baseline in BMD at the lumbar spine, total hip, and femoral neck at Months 24 and 36
    During the 12-month double-blind ALN-controlled study period
    • Subject incidence of clinical fracture (nonvertebral fracture and clinical vertebral fracture) through Month 12
    • Subject incidence of new vertebral fracture through Month 12
    • Subject incidence of all fractures (nonvertebral fracture and new or worsening vertebral fracture) through Month 12
    • Percent change from baseline in BMD at the lumbar spine, total hip and femoral neck at Month 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12 and 24
    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 No
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA162
    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
    Bulgaria
    Canada
    Denmark
    France
    Greece
    Ireland
    Italy
    Austria
    Netherlands
    New Zealand
    Norway
    Romania
    Slovakia
    Sweden
    Dominican Republic
    Argentina
    Australia
    Brazil
    Chile
    Colombia
    Czech Republic
    Estonia
    Finland
    Germany
    Guatemala
    Hong Kong
    Hungary
    Latvia
    Lithuania
    Spain
    Israel
    Mexico
    Peru
    Poland
    Russian Federation
    South Africa
    Turkey
    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
    End of study (primary completion and end of trial) is defined as the time when clinical fracture events (nonvertebral fracture or clinical vertebral fracture) have been confirmed for at least 330 subjects but not before all subjects have had the opportunity to complete the Month 24 visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3850
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1265
    F.4.2.2In the whole clinical trial 4000
    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)
    Normal treatment of the condition
    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 Decision2013-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
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