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    Summary
    EudraCT Number:2010-021395-28
    Sponsor's Protocol Code Number:B3D-MC-GHDN
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-24
    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 ConcernedLatvia - SAM
    A.2EudraCT number2010-021395-28
    A.3Full title of the trial
    Effect of Teriparatide on Femoral Neck Fracture Healing
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of Teriparatide on Hip Fracture Healing
    A.3.2Name or abbreviated title of the trial where available
    GHDN
    A.4.1Sponsor's protocol code numberB3D-MC-GHDN
    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 SponsorEli Lilly and Company
    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 supportSynthes GmBH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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 Yes
    D.2.1.1.1Trade name Forsteo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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 nameteriparatide
    D.3.2Product code LY333334
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNTERIPARATIDE
    D.3.9.1CAS number 52232-67-4
    D.3.9.2Current sponsor codeLY333334
    D.3.9.4EV Substance CodeSUB10925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 No
    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 placeboInjection
    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
    Low trauma femoral neck fracture
    E.1.1.1Medical condition in easily understood language
    Hip Fracture
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068399
    E.1.2Term Trochanteric femoral 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 determine the effect of 6 months of treatment with teriparatide 20 μg/day versus placebo on the proportion of men and postmenopausal women ≥50 years of age with successful fracture healing 24 months after internal fixation of a low trauma femoral neck fracture
    E.2.2Secondary objectives of the trial
    Comparing the teriparatide group versus the placebo group on:

     The proportion of patients with radiographic evidence of healing, no revision surgery, functional evidence of healing, and pain control at 10 weeks, and 6, 12, and 24 months, and over time from 10 weeks to 24 months

     The proportion of patients who regain their prefracture ambulatory status at each postsurgical visit and over time from the first postsurgical visit to 24 months

     The time to revision surgery over 24 months

     Patient-reported outcomes as measured by the mean change in Short Form-12 (SF-12), Western Ontario McMaster Osteoarthritis Index (WOMAC), and European Quality of Life Questionnaire (EQ-5D) from the first postsurgical visit to 6 months.

     Safety as assessed by clinical laboratory tests and AEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Community dwelling men and postmenopausal women aged ≥50 years who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture

    Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years

    Have received or are eligible for treatment with internal fixation

    Have given written informed consent
    E.4Principal exclusion criteria
    Increased baseline risk of osteosarcoma

    History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis and any secondary causes of osteoporosis

    Abnormally elevated values of serum calcium at baseline

    Abnormally elevated values of serum intact parathyroid hormone (PTH) (1-84) at baseline

    Severe vitamin D deficiency at baseline defined as 25-hydroxy-vitamin D levels <9.2 ng/mL

    Active liver disease or jaundice

    Significantly impaired renal function at baseline

    Abnormal thyroid function not corrected by therapy

    History of a malignant neoplasm in the 5 years prior to Visit 1, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.

    History of bone marrow or solid-organ transplantation

    History of symptomatic nephrolithiasis or urolithiasis in 1 year prior to visit

    Prior treatment with PTH, teriparatide or other PTH analogs

    Local or systemic treatment with bone morphogenic proteins or any growth factor

    Previous fracture or bone surgery in the currently fractured hip

    Treatment with bone grafting or osteotomies

    Soft tissue infection at the operation site

    Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants or with non-invasive interventations

    Polytrauma patients and patients with fracture at more thatn 1 site.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with successful fracture healing at 24 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 month visit
    E.5.2Secondary end point(s)
    To compare the teriparatide group versus the placebo group on the proportion of patients with

    1.radiographic evidence of healing at 10 weeks, and 6, 12, and 24 months and over time from 10 weeks to 24 months.

    2.no revision surgery at each postsurgical visit and over time from the first postsurgical visit to 24 months

    3.able to ambulate with a gait speed of ≥0,05 meters/second (m/s) at 24 months, with or without a walking aid, and have no clinically significant decrease in gait speed (>0,1 ms/) from baseline to 24 months

    4.able to ambulate without severe fracture-site pain at 24 months and have no clinically significant increase in worst fracture-site pain during ambulation from baseline to 24 months

    5.able to ambulate with a gait speed of ≥0,05 m/s at 10 weeks, and 6, 12, and 24 months and over time from 10 weeks to 24 months.

    6.without severe fracture-site pain in the 24 hours preceding a visit, on weight bearing, and during ambulation at 10 weeks, and 6, 12, and 24 months and over time from 10 weeks to 24 months.

    7.who regain their prefracture ambulatory status at each postsurgical visit and over time from the first postsurgical visit

    8.The mean change over time from 10 weeks to 6 months in worst fracture-site pain in the 24 hours preceding a visit, on weight bearing and during ambulation

    9.The mean change over time from 10 weeks to 6 months in gait speed

    10.The time to revision surgery over 24 months

    11.Patient-reported outcomes

    12. Safety as assessed by lab tests and AEs
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 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 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    Australia
    Austria
    Brazil
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    New Zealand
    Norway
    Poland
    Romania
    South Africa
    Sweden
    Switzerland
    Taiwan
    Turkey
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 610
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 610
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the ICD is signed by proxy (for example, in the perioperative period), the patient should also sign the ICD at the earliest visit that they are able to do so.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 430
    F.4.2.2In the whole clinical trial 1220
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CCBR
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-04
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