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    Summary
    EudraCT Number:2012-002948-24
    Sponsor's Protocol Code Number:20080289
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-002948-24
    A.3Full title of the trial
    An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment with AMG 785 in Postmenopausal Women with Osteoporosis Previously Treated with Bisphosphonate Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Effect of Treatment with AMG 785 in Postmenopausal Women with Osteoporosis Previously Treated with BisphosphonateTherapy
    A.3.2Name or abbreviated title of the trial where available
    STRUCTURE
    A.4.1Sponsor's protocol code number20080289
    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
    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.3.2Product 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.3.9.2Current sponsor codeAMG785
    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 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 Forsteo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly
    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 nameForsteo
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    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 INNTERIPARATIDE
    D.3.9.1CAS number 52232-67-4
    D.3.9.4EV Substance CodeSUB10925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Menopausal Osteoporosis
    E.1.1.1Medical condition in easily understood language
    Post Menopausal 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
    Evaluate the effect of treatment with AMG 785 for 12 months, compared with teriparatide (TPTD), on total hip bone mineral density (BMD), as assessed by dual energy X-ray
    absorptiometry (DXA), in postmenopausal women with osteoporosis, previously treated with bisphosphonate (BP) therapy.
    E.2.2Secondary objectives of the trial
    Evaluate the effect of treatment with AMG 785 for 12 months, compared with TPTD, on the following:
    • integral and cortical BMD at the total hip, as assessed by quantitative computed tomography (QCT)
    • QCT bone mineral content (BMC) and estimated strength by finite element analysis (FEA) at the total hip
    • BMD by DXA at the femoral neck and lumbar spine
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Ileac Crest Bone Biopsy.
    Up to 20 romosozumab-treated subjects will be recruited to undergo a
    transiliac bone biopsy at month 12 to assess the effect of romosozumab
    treatment on parameters of bone histology and histomorphometry.
    Subjects will need to provide separate informed consent specific to the biopsy procedure in order to participate.
    E.3Principal inclusion criteria
    - Ambulatory, postmenopausal women, aged ≥ 55 to ≤ 90 at randomization. Postmenopause is defined as no vaginal bleeding or spotting for 12 consecutive months prior to screening.
    - Received oral bisphosphonate therapy at a dose approved for
    postmenopausal osteoporosis for at least 3 years immediately prior to screening.
    - At least 75% compliant (as reported by the subject) with bisphosphonate administration over the previous 3 years immediately prior to screening.
    - At least 75% compliant (as reported by the subject) with alendronate (70 mg weekly or equivalent) administration during the 1 year immediately prior to screening.
    - BMD T-score ≤ -2.50 at the lumbar spine, total hip or femoral neck, as assessed by the central imaging vendor at the time of screening, based on DXA scans.
    - History of nonvertebral fracture after age 50, or vertebral fracture.
    - At least 2 vertebrae in the L1-L4 region and at least one hip that are evaluable by DXA
    - Subject has provided informed consent
    E.4Principal exclusion criteria
    - Use of the following agents affecting bone metabolism:
    • 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
    • Denosumab or any cathepsin inhibitor, sucha as odanacatib (MK-0822): dose received within 18 months prior to randomization
    • TPTD or any PTH analogs: more than 12 months of cumulative use or dose received within 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: 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 study results, such as sclerosteosis, Paget's disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, and malabsorption syndrome
    - 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 hyper- or hypocalcemia, defined as albumin adjusted serum calcium outside the normal range, as determined by the central laboratory. Albumin-adjusted serum calcium levels may be retested once in case of an elevated albumin-adjusted 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 and thyroxine 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
    - Subjects 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 transplants
    - Known to have human immunodeficiency virus hepatitis C virus, or hepatitis B infection
    TPTD-related exclusion criteria (for all subjects)
    - Hypersensitivity to TPTD or any of the excipients (eg, glacial acetic acid, sodium acetate, mannitol, metacresol, hydrochloric acid, sodium hydroxide)
    - Severe renal impairment, (as assessed by the central laboratory based on a derived creatinine clearance of < 35 mL/min using the Modification of Diet in Renal Disease equation [Levey et al, 2006]). The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 175 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.212 if subject is
    black].
    - Unexplained elevations of alkaline phosphatase (> 1.5x ULN)
    - Skeletal malignancies or bone metastases
    - Prior external-beam or implant radiation therapy
    - Known active or recent urolithiasis
    General exclusion criteria (for all subjects)
    - Receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
    - Other investigational procedures are excluded.
    - Malignancy within the last 5 years, except non-melanoma skin cancers,
    cervical or breast ductal carcinoma in situ.
    - Known sensitivity to any of the products or known intolerance to any of the products or components to be administered (calcium supplements, vitamin D products, or mammalian cell derived products)
    - Pregnant or planning to become pregnant within 3 months after the last dose of IP
    - Previous participation in this study or prior participation in a study with a sclerostin antibody product
    - 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.
    - Metal implants or hardware at either hip (ie, sliding nail, total endoprosthesis)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percent change from baseline in DXA BMD at the total hip through Month 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 12
    E.5.2Secondary end point(s)
    Key secondary endpoints, which will be included in the test sequence, are as follows:
    • Percent change from baseline in BMD by DXA at the total hip at Month 6
    • Percent change from baseline in BMD by DXA at the total hip at Month 12
    • Percent change from baseline in cortical BMD by QCT at the total hip at Month 6
    • Percent change from baseline in cortical BMD by QCT at the total hip at Month 12
    • Percent change from baseline in BMD by QCT at the total hip at Month 6
    • Percent change from baseline in BMD by QCT at the total hip at Month 12
    • Percent change from baseline in estimated strength by FEA at the total hip at Month 6
    • Percent change from baseline in estimated strength by FEA at the total hip at Month 12
    Other secondary endpoints, which will not be included in the test sequence, are as follows:
    • Percent change from baseline in QCT BMC at the total hip at Month 6 and Month 12
    • Percent change from baseline in BMD by DXA at the femoral neck at Month 6 and Month 12
    • Percent change from baseline in BMD by DXA at the lumbar spine at Month 6 and Month 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 6 and Month 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 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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    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
    Canada
    Denmark
    Argentina
    Colombia
    Czech Republic
    Hungary
    Spain
    Poland
    United Kingdom
    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 years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 300
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 301
    F.4.2.2In the whole clinical trial 400
    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 Decision2013-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
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