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    Summary
    EudraCT Number:2004-000894-67
    Sponsor's Protocol Code Number:B3D-MC-GHCN
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-07-02
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-000894-67
    A.3Full title of the trial
    The Effect of Teriparatide on Distal Radius Fracture Healing
    A.3.2Name or abbreviated title of the trial where available
    GHCN
    A.4.1Sponsor's protocol code numberB3D-MC-GHCN
    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 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 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.2.5The 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 Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 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 Yes
    D.3.11.13.1Other medicinal product typerecombinant fragment [hPTH(1-34)] of PTH hormone
    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
    Fracture of distal radius (Colles’) fracture
    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
    The primary objective of this study is to compare the effect of 8 weeks of subcutaneous treatment with teriparatide 20 or 40 μg/day versus placebo on time to radiographic fracture healing, (defined by cortical bridging) in postmenopausal women with a unilateral, dorsally angulated, distal radius (Colles’) fracture.
    E.2.2Secondary objectives of the trial
    Radiologic:
    ·Time to early endosteal as well as partial endosteal healing as evidenced by radiographs and computed tomography (CT scan)
    ·Time to trabecular union as evidenced by radiographs and CT scan
    ·Time to cortical bridging as evidenced by CT scan
    ·Evaluation of anatomical deformity as evidenced by radiographs.
    Functional/Clinical:
    ·Assessment of pain and hand function via the self administered Patient Rated Wrist Evaluation (PRWE).
    Assessment of disability of the arm, shoulder, and hand via the self?administered Disabilities of the Arm, Shoulder, and Hand (DASH) outcome measure.
    ·Assessment of grip strength via a JAMAR dynamometer.
    ·Assessment of wrist Range of Motion (ROM).
    ·A Mayo wrist score calculated from other functional assessments.
    Safety:Assessment of vital signs, clinical laboratory tests, and reports of adverse events.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Most important inclusion criteria:
    [1]Ambulatory, postmenopausal, women 45 to 80 years of age. Postmenopausal is defined as at least 2 years without regular menses.
    [2]Sustained a unilateral, dorsally angulated fracture of the distal radius within past one week.
    [3]Received conservative treatment of her distal radius fracture, including closed reduction and immobilization device (such as cast, splint, brace, or other).
    [4]Free of severe or chronically disabling conditions other than a distal radius fracture as determined by the investigator.
    [5] Without language barrier, cooperative, expected to return for all follow-up procedures, and has given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study.
    [6]In the opinion of the investigator, the patient is willing to be trained and use the pen-injector daily or is willing to receive daily subcutaneous injections from a care partner who has been trained to use the pen injector.
    E.4Principal exclusion criteria
    Patients will be excluded from the study for any of the 25 exclusion criteria. Most important are:
    [7] No restrictions on concomitant medications after study endpoint, Visit 11 (Week 17) except for oral strontium renalate and flouride.
    [8] Increased baseline risk of osteosarcoma; this includes subjects with Paget’s disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation.
    [9] History of a malignant neoplasm in the 5 years prior to Visit 2, 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 entry into the study may enter the study.
    [10] Have currently known, suspected, or history of other diseases that:
    ·affect bone metabolism, other than postmenopausal osteoporosis (such as renal osteodystrophy or osteomalacia).
    ·cause secondary osteoporosis (such as hyperparathyroidism, hyperthyroidism, sprue, inflammatory bowel disease, or malabsorption syndrome) that has been clinically active in the 1 year prior to Visit 2.
    [11] Have elevated serum calcium values based on local laboratory reference ranges.
    [12] Active liver disease (liver enzymes more than three times the upper limit of normal) or clinical jaundice.
    [13] History of symptomatic nephro- or urolithiasis in the 2 years prior to Visit 2.
    [14] Previous fractures or bone surgery in the currently fractured distal forearm.
    [15] Joint diseases such as rheumatoid arthritis or disabling osteoarthritis that clearly affect the function of the wrist and/or hand of the injured arm.
    [16] Requirement for chronic treatment with nonsteroidal anti?inflammatory drugs (NSAIDs, including Cox?2 inhibitors), defined as more than 3 consecutive months of any NSAID treatment. Dosages of aspirin for coronary heart disease prophylaxis £500 mg/day is acceptable. Patients may take NSAIDs after study endpoint (Week 17). Short-term use of NSAIDs for pain management is acceptable.
    [17] Treatment with:
    ·oral bisphosphonates for more than 2 consecutive months in the last 1 year, or have received any oral or intravenous bisphosphonate therapy within the last 6 months prior to screening. Patients may take bisphosphonates after study endpoint (Week 17).
    ·oral strontium renalate for any duration.
    ·systemic corticosteroids (other than for adrenal replacement therapy) for more than 30 days (total) in the 6 months prior to Visit 2, or any systemic corticosteroid dose in the 1 month prior to Visit 2. Ophthalmic, otic, topical, or nasally inhaled corticosteroid therapy may be used without these restrictions. Orally inhaled glucocortocsteriods will not exceed a daily dose of 800 mg of beclomethasone. Patients may take systemic corticosteriods after study endpoint (Week 17).
    ·fluoride at therapeutic doses (³20 mg/day) for more than 3 months during the last 2 years or for more than a total of 2 years, or any dosages within the 6 months prior to Visit 2 (previous or current use of fluoridated water or topical dental fluoride treatment is permitted).
    ·androgen or other anabolic steroids more recently than 6 months prior to Visit 2. Patients may take androgens or other anabolic steriods after study endpoint (Week 17).
    [18] History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to Visit 2, in the opinion of the investigator.
    [19]Poor medical or psychiatric condition for treatment with an investigational drug, in the opinion of the investigator.
    [20] Have a known allergy to teriparatide, any diluents or excipients of teriparatide, or to any other form of PTH or PTH analog.
    [21] Have received treatment within the previous 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    [22] Participation in any other clinical study studying teriparatide or have received prior treatment with PTH or a PTH fragment or analog.
    [23] Patients are not permitted to join any clinical studies involving drugs or indications not approved by the FDA at any time during their participation in the distal radius fracture study.
    [24] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator?site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    [25] Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for the conduct the study). Immediate family of Lilly employees may participate in Lilly sponsored clinical studies, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is the time to a radiographically healed fracture. This is defined as the interval, in days, between the occurrence of the fracture and the time when bridging of the four cortices is determined by x-ray film.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 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
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 105
    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 Decision2004-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
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