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    Summary
    EudraCT Number:2010-020081-22
    Sponsor's Protocol Code Number:R&D 2185
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2010-12-10
    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 number2010-020081-22
    A.3Full title of the trial
    The administration of Parathyroid hormone affects functional recovery from pertrochanteric fractured neck of femur: A prospective randomised comparative pilot study with blinded objective functional outcome assessment.
    A.3.2Name or abbreviated title of the trial where available
    Parathyroid Hormone in the recovery from hip fractures - a pilot study
    A.4.1Sponsor's protocol code numberR&D 2185
    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 SponsorNorth Bristol NHS Trust
    B.1.3.4Country
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Forsteo
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameParathyroid Hormone
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNTeriparatide
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20/80
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoporotic or low energy pertrochanteric hip fractures
    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 pilot study is to establish the potential recruitment, compliance and drop out rates for the intervention and the feasibility of the trial design. The research team will use the experience of the pilot study to further develop patient information, train staff taking consent, and to set up a management strategy to deliver an effective and successful multi-centre trial in the future. The experience of running this pilot study will enable the research team to predict potential difficulties in recruiting to the trial design and successfully deliver a trial that answers the main question regarding the potential for parathyroid hormone.
    E.2.2Secondary objectives of the trial
    The second objective of the study is to define the ‘standard’ medicinal care for these fragility fractures in the comparison group. The NICE guidelines for osteoporosis treatment should be initiated following occurrence of a fragility fracture. The NICE guidelines are summarised in the protocol. This study is not a direct comparison of Parathyroid hormone and Bisphosphonates, therefore it will be important to clarify aspects of the comparison group such as time until treatment initiation, which treatments are started and the referral for, timing of and results of a DEXA scan.

    The third objective is to pilot the outcomes measures, in particular the objective functional score (the Short Physical Performance Battery - SPPB). It will assess the ease of completion, suitability for the patient group and environment, and clarify training needs for future trial staff. The SPPB has well documented and researched validity, sensitivity and clinically significant change in score for this popul
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must be 60 years and over admitted to North Bristol NHS Trust with a pertrochanteric femoral fracture.
    E.4Principal exclusion criteria
    Patients fulfilling any of the following criteria would be excluded from the trial.
    1.Fracture not result of low energy trauma e.g fall from standing height
    2.Conservative treatment
    3.Surgical fixation with THR, hemiarthroplasty or cannulated screws
    4.Previous treatment with PTH or other PTH analogues
    5.Previous IV bisphosphonates e.g Zoledronic acid infusion in the previous 12 months
    6.Previous treatment with Strontium in the previous 12 months
    7.Current medications for breast and prostrate cancer (e.g tamoxifen, anastrozole, zoladex, prostap) or other current hormone therapy e.g. testerone, HRT
    8.Decreased capacity to understand and the weigh the risks and benefits of participating in the trial
    9.Presence of a metabolic bone disease e.g. Pagets disease of hyperparathyroidism
    10.High or Low corrected calcium which requires investigation
    11.Severe renal failure, urolithiasis or hypercalcaemia
    12.Unexplained raised alkaline phosphatase
    13.Active cancer diagnosis or skeletal malignances or bone metastases, or prior external beam or implant radiation therapy to skeleton within the last five years
    14.Pre-menopausal, Pregnancy or lactation
    15.Sustained use of oral steroids
    16.Wheelchair, bed bound or transfers only prior to fracture
    17.Other fractures that will affect ability to mobilise at 6 weeks
    18.Physical capability to carry out treatment protocol or appropriate social circumstances (e.g. needle phobia, other severe disabilities limiting manipulation injection pen and without appropriate carer willing and able to assist)
    19.Patient consents to study >7 days post surgery
    20.Patients currently involved in other clinical trial of medicinal products
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this pilot study will be participant numbers. Data regarding the numbers of patients eligible for the study (fulfilling inclusion criteria), numbers excluded and reasons for exclusion, numbers of patients approached, consenting and reasons not consenting when given will be collected. Data regarding patients lost to follow-up or withdrawing consent and where possible reasons will be documented. Adverse reactions will be monitored and documented, as well as mortality within 3 and 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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    normal care
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    When the last patient completes the 12 month period in the study i.e. last subject last visit
    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 months6
    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 months6
    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 Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Once the 6 week intervention (PTH injection) has been completed the patients GP will be informed and they will be recommended to continue with treatment for osteoporosis as normal and recommended by NICE guidelines.
    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 Decision2011-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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