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    Summary
    EudraCT Number:2009-015939-33
    Sponsor's Protocol Code Number:20080394
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-10-18
    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 ConcernedFinland - Fimea
    A.2EudraCT number2009-015939-33
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Determine the Efficacy, Safety, and Tolerability of AMG 785 in Adults with a Fresh Unilateral Hip Fracture, Status Post Surgical Fixation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of AMG785 in hip fracture
    A.4.1Sponsor's protocol code number20080394
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01081678
    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, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post code(CH) 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 nameAMG 785
    D.3.2Product code AMG 785
    D.3.4Pharmaceutical form Solution for injection
    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 codeAMG 785
    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 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
    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
    Acceleration of fracture healing
    E.1.1.1Medical condition in easily understood language
    Fracture Healing
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10016454
    E.1.2Term Femur fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of AMG 785 compared to placebo on functional healing as measured by the timed-up-and-go test (TUG) over Weeks 6 through 20 in subjects with fresh unilateral low energy hip fractures.
    E.2.2Secondary objectives of the trial
    To investigate the effect of AMG 785 compared to placebo on:
    (1) TUG value by visit
    (2) Time to radiographic healing defined as effacement of the fracture lines by newly formed bone along the cortices and within the trabecular bone on anteroposterior (AP) & lateral (or oblique) radiographs
    (3) Radiographic Union Scale for Hip (RUSH) score by visit
    (4) Harris Hip Score
    (5) Pain as a result of the hip fracture as assessed by the Visual Analog Scale (VAS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Dual energy X-ray Absorptiometry (DXA) and PK/PD sub-study, version dated 22 October 2009:
    Approximately 40 subjects per arm (approximately 160 subjects in total) will be enrolled into this sub-study to undergo DXA scans of the lumbar spine and proximal femur and have blood drawn for
    PK/PD analysis. This sub-study will evaluate the percent change from baseline on lumbar spine and hip BMD at Week 52. Blood samples will be used for assessment of AMG 785, sclerostin, and bone turnover markers P1NP and CTX.
    The evaluation of the Dutch version of the Hip disability and Osteoarthritis Outcome Score (HOOS) as an outcomes instrument in a hip fracture population will be performed in the Netherlands.


    E.3Principal inclusion criteria
    Adult women or men, age ≥ 55 to ≤ 95 years at randomization

    Fresh unilateral low energy intertrochanteric or femoral neck fracture as the primary injury, confirmed by X-ray and in the opinion of the treating surgeon amenable to repair by internal fixation

    Intertrochanteric fractures eligible for this study must have at least two displaced fragments

    Internal fixation of the fracture with devices approved by local regulatory agency, performed no later than 7 days after injury for intertrochanteric or undisplaced femoral neck fractures and no later than 2 days after injury for displaced femoral neck fractures
    • Intertrochanteric fracture: sliding hip screw or IM nail
    • Femoral neck fracture: sliding hip screw or at least three cancellous screws

    Pre- and postoperative care performed as defined in Appendix I

    Subject or subject’s legally acceptable representative has provided informed
    consent
    E.4Principal exclusion criteria
    Conditions that may affect the ability to perform functional or clinical
    assessments required by the protocol, such as:

    • Severe symptomatic osteoarthritis of the lower extremity
    • Inability to independently rise from armchair or walk 200 meters before hip
    fracture (use of unilateral assistive device or rolling walker is acceptable)
    • Cognitive deficit, as defined by Mini-Mental Status Examination score < 22 at
    time of randomization
    • Symptomatic neurological conditions such as Parkinson’s disease or persistent
    gross motor or sensory deficits such as hemiparesis or hemiplegia
    • Presence of concomitant injuries such as rib fractures, wrist fractures, or acute
    symptomatic vertebral fractures which severely impair the ability to rise from a
    chair
    • Associated extremity injuries including ipsilateral or contralateral fractures of the
    foot, tibia or fibula, wrist, humerus, femoral shaft, femoral head or hip dislocation,
    that may delay weight-bearing beyond one week after surgery

    Use of bone grafts or bone substitutes at the time of fracture fixation

    Head-injury, as defined by Glasgow Coma Scale <13 prior to randomization

    Major polytrauma or significant axial trauma, with Injury Severity Score > 16

    Pathological fracture or history of metabolic or bone disease (except
    osteoporosis) that may interfere with the interpretation of the results, such as Paget’s disease, rheumatoid
    arthritis, osteomalacia, osteopetrosis, ankylosing spondylitis, Cushing’s disease,
    hyperprolactinemia

    History of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study

    History of facial nerve paralysis

    Malignancy (except fully resected cutaneous basal cell or squamous cell
    carcinoma, cervical carcinoma in situ) within the last 5 years

    Severe asthma or severe chronic obstructive pulmonary disease or recent exacerbation

    Myocardial infarction or unstable angina pectoris within the last 12 months

    Current alcohol dependence

    History of solid organ or bone marrow transplants

    Per subject report, chart review or local laboratory result, evidence of currently abnormal values for the following:
    • Elevated transaminases (a) Serum aspartate aminotransferase ≥ 2.0 x
    upper limits of normal; (b) Serum alanine aminotransferase ≥ 2.0 x upper
    limits of normal
    • Significantly impaired renal function as determined by a derived creatinine
    clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease
    equation (Levey et al, 1999). The estimated glomerular filtration rate is
    calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2)
    = 186 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is
    female] x [1.210 if subject is black].
    • Hypocalcemia or hypercalcemia, outside of 1.1 x the normal range set by the local laboratory

    Known to have tested positive for human immunodeficiency virus, hepatitis C
    virus, or hepatitis B surface antigen

    - Use of the following agents affecting bone metabolism
    • Within the past 12 months: parathyroid hormone, strontium, fluoride (for osteoporosis)
    • Within the past 6 months: IV bisphosphonates, denosumab, odanacatib (MK-0822)
    • Within the past 3 months: calcitonin, tibolone, cinacalcet, systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days)

    Bone Morphogenetic Protein (BMP)-2 or BMP-7 at the time of definitive fracture fixation

    Subjects to be enrolled in DXA sub-study may not have had previous
    instrumentation with implants (ie, nails, screws, pins, plates) to either hip or lower
    spine

    General

    • Currently enrolled in another investigational device, drug, or biologics
    product study, or less than 30 days since ending another investigational
    device, drug, or biologics product study(s), or receiving other
    investigational agent(s).
    • Previous enrollment in an AMG 785 clinical study
    • Females of childbearing potential: Subject refuses to use an effective
    contraception (or true abstinence) during treatment with study product and for an
    additional 3 months after the end of treatment with study product (ie, 3 months
    after the week 12 study visit)
    Subject is pregnant (eg, positive human chorionic gonadotropin test) or breast
    feeding, or planning to become pregnant during treatment with study product or
    within 3 months after the end of treatment with study product (ie, 3 months after
    the Week 12 study visit)
    Subject has known sensitivity or intolerance to any of the products to be
    administered (calcium supplements, vitamin D products, or mammalian cell
    derived products)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in mean TUG (timed up-and-go) over Weeks 6 through Week 20 between the AMG 785 and placebo groups.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 6 and 20
    E.5.2Secondary end point(s)
    To investigate the effect of AMG 785 compared to placebo on:

    • TUG value by visit
    • Time to radiographic healing, defined as effacement of the fracture lines by newly formed bone along the cortices and within the trabecular bone on AP & lateral (or oblique) radiographs
    • RUSH score by visit
    • Harris Hip Score by visit
    • Pain score as measured by VAS by visit
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 2,6,12,16,20,24 and 36
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial4
    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 EEA51
    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
    European Union
    Argentina
    Australia
    Canada
    Hong Kong
    India
    New Zealand
    Switzerland
    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
    End of study (EOS) is defined as the date the last eligible subject completes the final
    study visit at Week 52.
    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 months0
    E.8.9.2In all countries concerned by the trial days0
    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: 30
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 230
    F.4.2.2In the whole clinical trial 330
    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 Decision2010-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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