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    Summary
    EudraCT Number:2005-004149-33
    Sponsor's Protocol Code Number:05-FNF-007
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-11-24
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2005-004149-33
    A.3Full title of the trial
    A randomized, controlled trial of the effect of Osigraft when used in the treatment of displaced femoral neck fractures – a pilot study
    A.4.1Sponsor's protocol code number05-FNF-007
    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 SponsorStryker Biotech, LLC
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Osigraft 3.5 mg powder for suspension for implantation
    D.2.1.1.2Name of the Marketing Authorisation holderHowmedica International S. de R. L., Division of Stryker Corporation
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOsigraft
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEptotermin alfa
    D.3.9.1CAS number 129805-33-0
    D.3.9.3Other descriptive namerhOP-1, recombinant human osteogenic protein 1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Displaced femoral neck fractures are classified as Garden III and IV according to the Garden classification system for femoral neck fractures.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level PT
    E.1.2Classification code 10016450
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective of this pilot study is to evaluate the following:

    1. The effects of Osigraft on clinical outcomes, bone healing and functional recovery in patients with displaced intra-capsular femoral neck fracture.
    2. To evaluate the safety of Osigraft under the conditions of the trial.
    3. To evaluate the feasibility of performing protocol procedures in preparation for a pivotal study.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be eligible for study participation, a subject must meet all of the following criteria:

    1. Subject is willing and able to understand, sign and date the study specific, Institutional Review Board/Ethics Committee approved patient informed consent and applicable privacy regulations.
    2. Subject must require surgical treatment of a displaced intra-capsular femoral neck fracture.
    3. Subject must undergo definitive surgical intervention within 48 hours of the fracture.
    4. Subject is skeletally mature (≥18 years of age or radiographic evidence of closure of epiphyses).
    5. Subject will be less than 80 years of age at the time of study treatment.
    6. Subject was able to ambulate independently prior to femoral neck fracture.
    7. Subject agrees to participate in the post-operative clinical evaluations.
    8. Subject is male, or female of non-childbearing potential, or female with a negative pregnancy test within 48 hours of definitive surgical intervention.
    E.4Principal exclusion criteria
    To be eligible for study participation, a patient must not meet any of the following criteria:

    1. Subject is a pregnant or nursing woman, or a woman planning to become pregnant within 1 year following treatment.
    2. Subject is of childbearing potential and is unwilling to use medically acceptable contraceptive methods such as surgical sterilization, hormonal contraceptives, barrier methods, or intrauterine devices so as to prevent pregnancy for one year following the internal fixation.
    3. Subject has received another experimental drug, biologic or device as part of a study concurrent to or within 3 months prior to giving informed consent for this study.
    4. Subject has a known hypersensitivity to any of the components of the product (e.g. recombinant human osteogenic protein (rhOP-1), type I bovine bone collagen matrix or other protein pharmaceuticals (e.g. monoclonal antibodies, gamma globulins)).
    5. Subject who has a clinically significant organic disease, including cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or established dementia or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial or potentially decrease survival or interfere with ambulation or rehabilitation.
    6. Subject has a history of malignancy.
    7. Subject whose fracture is the result of a tumor or infection.
    8. Subject with known metabolic bone disease or other condition (other than osteoporosis) which would negatively impact on the bone healing process (e.g. history of Paget’s disease or other osteodystrophy).
    9. Subject has a history of pathological fractures.
    10. Subject has a history of heterotropic ossification.
    11. Subject is receiving treatment with a drug that interferes with bone metabolism.
    12. Subject currently being treated with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed).
    13. Subject has radiographic evidence of osteoarthritis in the injured hip.
    14. Subject has a history of rheumatoid arthritis.
    15. Subject has other fractures that would interfere with ambulation or rehabilitation.
    16. Subject has previously received a bone morphogenic protein (e.g. Osigraft).
    17. Subject has had previous surgical intervention at the fracture site.
    18. Subject has a condition which places him/her at risk for osteomyelitis.
    19. Subject has an ASA Physical Status Classification greater than 2.
    20. Subject has a life expectancy less than 24 months.
    21. Subject whose fracture is anticipated to be reduced in an open procedure.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the following in preparation for a pivotal study:

    • Proportion of patients requiring secondary surgical intervention
    • Weight bearing as assessed by Investigator
    • Proportion of patients with non-union and/or avascular necrosis (as judged by blinded independent radiologists)
    • Time to radiological union (as judged by blinded independent radiologists)
    • Functional outcomes (SF-36, EQ-5D)
    • Safety profile including Adverse Event (AE) and Serious Adverse Event (SAE) rates
    • Harris and Charnley-D’Aubigne-Postel Hip Scores
    • Visual Analog Scale for pain (hip pain)
    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 Yes
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    The end of the trial occurs 24 months after the last patient is enrolled.
    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 months8
    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 months8
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-11-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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
    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 Decision2006-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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