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    The EU Clinical Trials Register currently displays   37751   clinical trials with a EudraCT protocol, of which   6186   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-015939-33
    Sponsor's Protocol Code Number:20080394
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-21
    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 ConcernedItaly - Italian Medicines Agency
    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.3.2Name or abbreviated title of the trial where available
    STARTT-Hip
    A.4.1Sponsor's protocol code number20080394
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 nameAMG785
    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.3.9.2Current 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) 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.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10016454
    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
    FARMACOCINETICA/FARMACODINAMICA: Versione:Emend. 1 Data:2010/01/22 Titolo:Dual-energy X-ray Absorptimetry (DXA) and PK/PD sub-study Obiettivi:Circa 40 soggetti per braccio di trattatmento (approssimativamente 160 soggetti in totale) saranno arruolati nel sottostudio per esser sottoposti alla scansione
    DXA della colonna vertebrale e del femore prossimale e saranno sottoposti ad un prelievo per le analisi di farmacocinetica/farmacodinamica. Il sottostudio valutera` la percentuale di cambiamenti rispetto al basale della BMD della colonna vertebrale e dell`anca alla settiamana 52. I campioni di sangue saranno utilizzati per la valutazione di AMG 785, sclerostina, e dei marker del turnover osseo P1NP eCTX.

    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
    • 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 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 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
    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 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.8.3 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
    La visita di End of Study (EOS) e` definita come la data in cui l`ultimo soggetto elegibbile completa la visita finale dello studio alla settimana 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 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.1.3Elderly (>=65 years) Yes
    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 state24
    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 Decision2010-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-31
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