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    Summary
    EudraCT Number:2011-001116-65
    Sponsor's Protocol Code Number:B3D-MC-GHDQ
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2011-001116-65
    A.3Full title of the trial
    Second study of the 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
    Second study on the Effect of Teriparatide on Hip Fracture Healing
    A.3.2Name or abbreviated title of the trial where available
    GHDQ
    A.4.1Sponsor's protocol code numberB3D-MC-GHDQ
    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 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 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 PT
    E.1.2Classification code 10016450
    E.1.2Term Femoral neck 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 qssess 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 mo revision surgery 12 months after internal fixation of a low trauma femoral neck fracture
    E.2.2Secondary objectives of the trial
     The proportion of patients with radiographic evidence of healing, no revision surgery, functional evidence of healing, and pain control at 10 weeks, and 6 and 12 months, and over time from 10 weeks to 12 months

     The proportion of patients who regain their prefracture ambulatory status at each postsurgical visit and over time from the first postsurgical visit to 12 months

     The time to revision surgery over 12 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 adverse events.

    The proportion of patiens who demonstrate evidence of fracture healing as measured by all 4 of the following components at 12 months
    - radiographic evidence of healing
    - no revision surgery
    - functional evidence of healing, and
    - pain control
    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 (displaced or non-displaced)
    -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 (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not a part of this protocol)
    -Have given written informed consent (patient or proxy) after being informed of the risks, medications and study procedures
    E.4Principal exclusion criteria
    -Increased baseline risk of osteosarcoma; this includes patients with Paget’s diseaseof the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation, including external beam therapy or brachytherapy. As elevation of serum alkaline phosphatase may indicate the presence of Paget’s disease, an unexplained elevation of this enzyme is also exclusionary.
    -History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis including renal dystrophy, osteomalacia, including glucocorticoid-induced osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption
    -Abnormally elevated values of serum calcium at baseline defined as ≥10,6 mg/dL, except for clinically insignificant values as determined by the investigator in conjunction with the Lilly clinical research physician
    -Abnormally elevated values of serum intact parathyroid hormone (PTH) (1-84) at baseline defined as >72 pg/mL
    -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 based on serum creatinine and/or measured or calculated creatininethat, in the opinion of investigator, indicates significant renal impairment
    -Abnormal thyroid function not corrected by therapy
    -History of 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. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to screening may enter the study.
    -History of bone marrow or solid-organ transplantation
    -History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to Visit 1
    -Previous treatment with the following bone active drugs is allowed but must be discontinued at Visit 1: oral bisphosphonates, selective estrogen receptor modulators, calcitonin, estrogen (oral, transdermal or injectable), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active Vit D analogues. Androgen or other anabolic steroid use must be discontinued, except for use of physiologic replacement testosterone.
    -Previous treatment with the following bone active drugs is exclusionary, if the stated treatment durations have been met: strontium ranelate for any duration, intravenous bisphosphonates in the 12 months preceding Visit 1, and/or denosumab in the 6 months preceding Visit 1
    -Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation in any other clinical trial studying PTH, teriparatide or other PTH analogs
    -Local or systemic treatment with bone morphogenic proteins or any other growth factor
    -Previous fracture(s) or bone surgery in the currently fractured hip
    -Soft-tissue infection at the operation site
    -Treatment with bone grafting or osteotomies
    -Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants, or with noninvasive interventions
    - Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head, or pelvis: dislocations of the ankle, knee, or hips.
    E.5 End points
    E.5.1Primary end point(s)
    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 mo revision surgery 12 months after internal fixation of a low trauma femoral neck fracture
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 month visit
    E.5.2Secondary end point(s)
    To compare the teriparatide group versus the placebo group on
    - radiographic evidence of healing at 10 weeks, 6 months, and 12 months and over time from 10 weeks to 12 months.
    - no revision surgery at each postsurgical visit and over time from the first postsurgical visit to 12 months
    - able to ambulate with a gait speed of ≥0,05 meters/second (m/s) at 12 months, with or without a walking aid, and have no clinically significant decrease in gait speed (>0,1 ms/) from baseline (≥10 weeks) to 12 months
    - able to ambulate without severe fracture-site pain (<7 on pain Numeric Rating Scale [NRS]) at 12 months and have no clinically significant increase in worst fracture-site pain during ambulation (increase of >2 on pain NRS) from baseline (≥10 weeks) to 12 months
    - able to ambulate with a gait speed of ≥0,05 m/s at 10 weeks, 6 and 12months, and over time from 10 weeks to 12 months.
    - without severe fracture-site pain (NRS score of <7) in the 24 hours preceding a visit, on weight bearing, and during ambulation at 10 weeks, and 6 and 12 months and over time from 10 weeks to 12 months.
    - who regain their prefracture ambulatory status at each postsurgical visit and over time from the first postsurgical visit
    - The mean change over time from 10 weeks to 6 months in worst fracture-site pain in the 24 hours preceding a visit, on weigh bearing and during ambulation
    - The mean change over time from 10 weeks to 6 months in gait speed
    - The time to revision surgery over 12 months
    - Patient-reported outcomes as measured by the mean change over time from the first postsurgical visit to 6 months on the following:
    • Short Form 12 (SF-12) physical and mental component summary scores
    • Western Ontario McMaster Osteoarthritis Index (WOMAC)
    • European Quality of Life Questionnaire (EQ-5D)
    - Safety as assessed by clinical laboratory tests and adverse events (AEs)
    - The proportion of patients who demonstrate evidence of fracture healing as measured by all 4 of the following components at 12 months: 1/ radiographic evidence of healing, 2/ no revision surgery, 3/ functional evidence of healing 4/ pain control
    Endpoints are of equal importance
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 weeks to 12 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Argentina
    Austria
    Belgium
    Brazil
    Canada
    Croatia
    France
    Germany
    Greece
    Hungary
    India
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Slovenia
    Switzerland
    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 years2
    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 years2
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 40
    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)
    No
    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 Decision2012-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-20
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