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    Summary
    EudraCT Number:2013-001279-19
    Sponsor's Protocol Code Number:20120187
    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:2014-03-17
    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 number2013-001279-19
    A.3Full title of the trial
    A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and
    Safety of Denosumab Produced by Two Different Processes in
    Postmenopausal Women With Osteoporosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to find out more about the efficacy and safety
    of denosumab produced by two different processes in postmenopausal
    women with osteoporosis.
    A.4.1Sponsor's protocol code number20120187
    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.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 namedenosumab (manufactured using new process CP4)
    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.3.9.1CAS number 615258-40-7
    D.3.9.3Other descriptive nameDENOSUMAB
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 No
    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 Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namedenosumab
    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.3.9.1CAS number 615258-40-7
    D.3.9.3Other descriptive nameDENOSUMAB
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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
    Post Menospausal Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Post Menospausal 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 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
    The primary objectives of this study are to evaluate
    1. whether the efficacy of denosumab (60 mg subcutaneously every 6
    months) manufactured by the proposed process referred to as CP4 is not inferior to that of denosumab manufactured by the currently approved commercial process referred to as CP2 based on the change in lumbar spine bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) at 12 months in postmenopausal women with osteoporosis;
    2. whether the efficacy of denosumab CP4 (60 mg subcutaneously every
    6 months) is equivalent to that of denosumab CP2 based on the change
    in lumbar spine BMD by DXA at 12 months in postmenopausal women
    with osteoporosis.
    E.2.2Secondary objectives of the trial
    To compare the change in bone turnover marker levels over 12 months
    in subjects administered denosumab manufactured by 2 different
    processes in postmenopausal women with osteoporosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Ambulatory postmenopausal women. Ambulatory is defined as women who are able to walk, not bedridden; postmenopause is defined as no vaginal bleeding or spotting for at least 12 months prior to screening.
    • Age ≥ 55 years
    • Screening bone mineral density (g/cm2) values (by DXA) at the
    lumbar spine values equal to or less than 0.880 GE Lunar, 0.772 Hologic.
    Screening bone mineral density (g/cm2) values (by DXA) at the
    total hip values equal to or less than 0.693 GE Lunar, 0.637 Hologic.
    Screening bone mineral density (g/cm2) values (by DXA) at the
    femoral neck values equal to or less than 0.692 GE Lunar, 0.558 Hologic.
    Both the initial and the repeat DXA assessments at baseline of the
    lumbar spine OR the total hip OR the femoral neck must meet the above eligibility criteria.
    Eligibility will be determined by a local reading of the DXAs at the
    investigator's site. At least 2 lumbar vertebrae must be evaluable by
    DXA.
    • Subject's legally acceptable representative has provided informed
    consent prior to any study-specific activities/procedures being initiated
    when the subject has any kind of condition that, in the opinion of the
    investigator, may compromise the ability of the subject to give written
    informed consent.
    E.4Principal exclusion criteria
    • Height, weight, or girth which may preclude accurate DXA
    measurements
    • Received other osteoporosis treatment or bone active treatment with the following guidelines:
    - Administration of the following within the last 5 years
    . intravenous bisphosphonate
    . denosumab
    . fluoride for osteoporosis
    . strontium salts
    . PTH or PTH derivatives
    • Administration or oral bisphosphonates
    . > 3 years cumulatively, OR
    . > 3 months and ≤ 3 years cumulatively, unless treatment was
    discontinued ≥ 1 year prior to screening
    • Administration of any of the following treatment within the last 3
    months:
    . SERM (selective estrogen receptor modulator)
    . tibolone
    . anabolic steroids or testosterone
    . glucocorticosteroids (≥5 mg prednisone equivalent per day for > 10
    days or a total cumulative dose of ≥ 50 mg)
    . systemic hormone replacement therapy (HRT) (subjects stable on HRT
    for > 3 months prior are permitted)
    . antisclerostin antibody
    . calcitonin
    . other bone active drugs including anticonvulsants (except benzodiazepines, gabapentin) and heparin
    . cathepsin K inhibitor
    . chronic systemic ketoconazole, androgens, adreno corticotrophic
    hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors,
    gonadotropin releasing hormone agonists
    • Evidence of history of any of the following:
    . Current uncontrolled hypo- or hyperthyroidism (subjects who have
    controlled hypo- or hyperthyroidism may be eligible, provided that they
    have been on a stable therapy for at least 3 months (per subject
    report)).
    . hypo- or hyperparathyroidism
    . known to have tested positive for human immunodeficiency virus,
    hepatitis C virus, or hepatitis B surface antigen
    . osteomalacia (chart review)
    . osteonecrosis of the jaw (ONJ) or risk factors for ONJ such as invasive
    dental procedures (eg, dental implants, oral surgery in the past 6
    months), poor oral hygiene, periodontal and/or pre-existing dental
    disease
    . recent tooth extraction (within 6 months of screening visit)
    . Paget's disease of bone (subject report or chart review)
    . Rheumatoid arthritis
    . other bone diseases which affect bone metabolism (eg, osteopetrosis,
    osteogenesis imperfecta) (chart review)
    • Vitamin D deficiency (25[OH] vitamin D level < 20 ng/mL)
    • Creatinine clearance (calculated using the Cockcroft-Gault equation)
    of < 30 mL/min, or evidence of acute renal impairment
    • Abnormalities of the following per central laboratory reference
    ranges:
    . hypocalcemia or hypercalcemia
    . elevated transaminases ≥ 2.0 x upper limits of normal (ULN)
    • History of any solid organ or bone marrow transplant
    • Malignancy within the last 5 years (except squamous cell carcinoma,
    basal cell carcinoma, or cervical or breast ductal carcinoma in situ)
    • Contraindicated or poorly tolerant of denosumab therapy;
    contraindications include
    . hypocalcemia
    . hypersensitivity to drug or any component of the drug
    • Known intolerance to calcium or vitamin D supplements
    • Self reported alcohol or drug abuse within 12 months prior to
    screening
    • Any disorder that compromises ability to give truly informed consent
    for participation in this study
    • Currently enrolled in or has not yet completed at least 1 month since
    ending other investigational device or drug trial(s), or subject is
    receiving other investigational agent(s)
    • Subject has known sensitivity to any of the products to be
    administered during dosing
    • 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's 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
    • Subject previously has entered this study or any clinical trial involving
    denosumab
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from baseline in lumbar spine BMD at 12 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 months
    E.5.2Secondary end point(s)
    Percent change from baseline in bone turnover markers (serum CTX and
    P1NP) at 1, 6 and 12 months
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 1, 6 and 12 months
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    denosumab 60 mg Q6M (original process CP2)
    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 EEA15
    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
    Canada
    Denmark
    Czech Republic
    Poland
    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
    LVLS
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 150
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 300
    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 Decision2014-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-09
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