Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37736   clinical trials with a EudraCT protocol, of which   6184   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-015939-33
    Sponsor's Protocol Code Number:20080394
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-01-04
    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 ConcernedFrance - ANSM
    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 Fresh Unilateral Intertrochanteric Fracture of the Proximal Femur, Status Post Fixation with a Sliding Hip Screw or Intramedullary Nail
    A.4.1Sponsor's protocol code number20080394
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 INNAMG 785
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    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 intertrochanteric fracture of the proximal femur.
    E.2.2Secondary objectives of the trial
    To investigate the effect of AMG 785 compared to placebo on:

    • TUG by visit
    • Time to radiographic healing
    • Harris Hip Score
    • 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.
    E.3Principal inclusion criteria
    Adult women or men, age ≥ 55 to ≤ 90 years at randomization

    Fresh unilateral low energy intertrochanteric fracture of the proximal femur as the primary injury, confirmed by X-ray

    Fractures eligible for this study must have one of the following characteristics
    • At least three fragments, each with displacement ≥ 1 cm
    • Extension into the subtrochanteric region

    Internal fixation of the fracture with a sliding hip screw or IM nail (devices
    approved by local regulatory agency), performed no later than 5 days after injury

    Pre- and postoperative care performed as defined in Appendix J of the protocol

    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 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

    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 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

    Evidence of the following per subject report, chart review or local laboratory
    result (currently or within the past 5 years)

    • 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].
    • Current hypocalcemia or hypercalcemia (≥ 1.1 x upper limit of the normal
    range set by the local laboratory, after adequate volume resuscitation, is
    acceptable for high calcium value)

    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
    • Denosumab within the past 6 months
    • Fluoride (for osteoporosis) or IV bisphosphonates within the past 12 months
    • Parathyroid hormone or strontium within the past 12 months
    • Calcitonin within the past three months
    • Systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more
    than 10 days) within the past three months

    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 2 different
    forms of effective contraception (or true abstinence) in order to achieve a
    highly effective contraception result during treatment with study product
    and for an additional 5 months after the end of treatment with study
    product (5 months after the week 12 study visit)
    • Sexually active males with a female partner of childbearing potential:
    Subject in combination with his partner refuses to use 2 different forms of
    effective contraception (or true abstinence) in order to achieve a highly
    effective contraception result during treatment with study product and for
    an additional 3 months after the end of treatment with study product
    (3 months after the week 12 study visit)
    • Male subject with a partner who is pregnant: Subject refuses to use a
    condom during treatment with study product and for an additional
    3 months after the end of treatment with study product (3 months after the
    week 12 study visit)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the difference in mean TUG over Weeks 6 through Week 20 between the AMG 785 and placebo groups.
    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 Information not present in EudraCT
    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.8.3 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 EEA35
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 230
    F.4.2.2In the whole clinical trial 330
    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 Decision2010-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-23
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA