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    Summary
    EudraCT Number:2011-000988-28
    Sponsor's Protocol Code Number:19403
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-000988-28
    A.3Full title of the trial
    Fractures and Bisphosphonates: A double-blind, randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes of wrist fractures
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fractures and Bisphosphonates: do bisphosphonates affect fracture healing?
    A.3.2Name or abbreviated title of the trial where available
    Fractures and Bisphosphonates - the FaB trial
    A.4.1Sponsor's protocol code number19403
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN62133820
    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 SponsorUniversity of Edinburgh
    B.1.3.4CountryUnited Kingdom
    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 supportArthritis Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportUniversity of Edinburgh
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointEdinburgh Clinical Trials Unit
    B.5.3 Address:
    B.5.3.1Street AddressWestern General Hospital
    B.5.3.2Town/ cityEdinburgh
    B.5.3.3Post codeEH4 2XU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01315373855
    B.5.5Fax number01315373851
    B.5.6E-mailectu@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    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 Alendronic Acid 70 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA UK Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAlendronic Acid
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAlendronic Acid
    D.3.9.1CAS number 66376-36-1
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Fracture healing
    E.1.1.1Medical condition in easily understood language
    Fracture healing
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10017076
    E.1.2Term 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
    The aim of the study is to determine if alendronic acid - the drug most commonly used in the UK as treatment of osteoporosis (thinning bones) - affects fracture healing. Participants will be randomised to receive either alendronic acid or a placebo (a tablet that contains no active drug).

    The main objective will be to look at the x-rays that are taken 4 weeks into the study and compare the number of healed fractures in each group (alendronic acid or placebo). We will also look at how long it takes a fracture to heal, using the x-rays taken at weeks 2, 4, 6 and 8.

    One person will analyse all the x-rays in the study. The x-rays will be anonymised so that the reviewer is unaware of individual details or the treatment that the participant received.
    E.2.2Secondary objectives of the trial
    We will also look at the outcomes of wrist fracture such as how well the wrist is working and the patient's pain.

    Wrist function will be compared between both groups using the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome measure. This is a 30 item questionnaire.

    Wrist function will also be measured by comparing the range of movement (i.e. flexibility) of a participant's wrist joint.

    The amount of pain a participant is in and the amount pain medication used will be compared between both groups.

    The grip strength of participants will be compared between both groups.

    Malunion (where the bone does not join up properly) of the fracture site will be assessed by X-ray at week 26. The presence and frequency of malunion will be compared between each group.

    Participants will also be assessed for Complex Regional Pain Syndrome type I (CRPS-I). This is a condition that can happen after a fracture and involves abnormal pain levels and other symptoms such as reduced
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Full Title:
    Fractures and Bisphosphonates: A double-blind, randomised controlled trial on the effect of alendronic acid on healing and clinical outcomes of wrist fractures - HIGH RESOLUTION PERIPHERAL QUANTITATIVE COMPUTED TOMOGRAPHY (HR-pQCT) SUB-STUDY.

    Protocol Version & Date:
    1.1, 6th July 2011

    Primary Objective:
    To determine the effect of alendronic acid on total volumetric bone density measured by HR-pQCT during radial fracture healing.
    E.3Principal inclusion criteria
    1. Patients (male and female) aged 50 years and over
    2. Patients must have suffered a distal radial fracture confirmed by X-ray radiograph.
    3. The distal radial fracture must be:
    i) unilateral extra-articular or minimal articular
    ii) displaced or un-displaced
    iii) treated with cast/splint, external fixation or open reduction and internal fixation.
    4. Patients willing and able to consent and comply with study protocol.

    For the HR-pQCT substudy, participants must also satisfy the following criteria:
    - a stabilized fracture using a plaster cast (with or without manipulation)
    - proximal extent of the fracture site must be within 2 cm of the lunate fossa
    - willing to undergo HR-pQCT scans of the wrist, at four of the main study visits, and incur a small additional exposure to ionizing radiation.
    E.4Principal exclusion criteria
    1. Any of the following:
    i) current or previous use of zoledronic acid
    ii) current or previous use within the last 2 years of any other bisphosphonate.
    iii) current or previous use within the last 6 months of strontium ranelate, calcitonin, Denosumab, parathyroid hormone (PTH) or IV, IM and oral corticosteroids (inhaled corticosteroids such as asthma inhalers are acceptable).
    2. Previous distal radial fracture on affected side.
    3. Bilateral distal radial fracture.
    4. Contraindications to alendronic acid, including but not limited to:
    i) abnormalities of the oesophagus and other factors which delay oesophageal emptying such as stricture or achlasia
    ii) inability to stand or sit upright for at least 30 minutes
    iii) hypersensitivity to alendronate or any of its excipients
    iv) known hypocalcaemia
    v) known renal impairment
    5. Women of child bearing potential not using adequate contraception.
    6. Pregnancy.
    7. The distal radial fracture is due to other pathologies e.g. Paget’s Disease of Bone, metastatic bone disease etc.

    For the HR-pQCT substudy, the following exclusion criteria also apply:
    - Unable or unwilling to provide informed consent for participation in the sub-study
    - Treatment of the fracture which involves the insertion of metal implants (e.g. wires, fixators or plate/screws)
    E.5 End points
    E.5.1Primary end point(s)
    Primary analysis will be measured by comparing the percentage of fractures healed in each treatment group (alendronic acid vs placebo) at 4 weeks.

    The study is designed and powered to allow a definitive comparison of fracture healing rates after 4 weeks of treatment. Since previous studies have yielded conflicting results we have also ensured that the study is adequately powered to perform a non-inferiority comparison assuming that fracture healing time with alendronate will be similar to that of placebo to within four days. The difference between groups will be assessed by comparing the proportion of participants whose fracture has healed by week 4 in each treatment group. However a time to event analysis will also be performed to evaluate the trajectory of fracture healing from radiographs taken at 2, 4, 6 and 8 weeks.

    Fractures will be defined as healed when the following features are present:
    1. Bridging of three out of four cortices
    2. Radiographic evidence of endosteal healing
    3. Organised trabecular bridging
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint will be measured at 4 weeks, with also an analysis of the trajectory of fracture healing from the radiographs taken at 2, 4, 6 and 8 weeks.
    E.5.2Secondary end point(s)
    1. The effect of alendronate on the DASH score during the trial will be measured by compared in both treatment groups.
    2. The presence of Complex Regional Pain Syndrome type I (CRPS-I) will be assessed compared between both treatment groups.
    3. The difference in pain and analgesia use will be compared between both treatment groups.
    4. The differences between the range of movement in each hand will be used to compare the two treatment groups.
    5. The difference in grip strength between each hand will be used to compare the two treatment groups.
    6. The presence of malunion will be compared between both treatment groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. The DASH score will be assessed at baseline, weeks 2, 4, 6, 8 and 26
    2. CRPS-I will be evaluated at week 6 and 26.
    3. Pain and analgesia use will be evaluated at baseline, weeks 2, 4, 6, 8 and 26
    4. Range of movement will be assessed at weeks 8 and 26.
    5. Grip strength will be assessed at weeks 8 and 26.
    6. Malunion will be assessed by radiograph at week 26.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned7
    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 No
    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
    End of trial is the last participant's last study visit. (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
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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)
    As the research is based on treatment during fracture healing it would not be appropriate to have a provision to continue treatment after the study has finished.

    Participants will be investigated for evidence of osteoporosis by DEXA according to local clinical practice and offered anti-osteoporotic therapy if this is discovered.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-03
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