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    Summary
    EudraCT Number:2016-004960-20
    Sponsor's Protocol Code Number:58246
    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:2016-12-22
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-004960-20
    A.3Full title of the trial
    Local zoledronate for improved fixation of uncemented hip prostheses.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Osteoporosis drugs to improve migration in patients with uncemented joint replacement
    of the hip
    A.4.1Sponsor's protocol code number58246
    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 SponsorRegion Östergötland
    B.1.3.4CountrySweden
    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 supportÖstergötland County Council
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportLink Sweden AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRegion Östergötland
    B.5.2Functional name of contact pointJörg Schilcher
    B.5.3 Address:
    B.5.3.1Street AddressOrtopedkliniken, Universitetssjukhuset
    B.5.3.2Town/ cityLinköping
    B.5.3.3Post code58185
    B.5.3.4CountrySweden
    B.5.4Telephone number0046101034312
    B.5.6E-mailjhschilcher@googlemail.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.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraosseous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZOLEDRONIC ACID
    D.3.9.1CAS number 118072-93-8
    D.3.9.4EV Substance CodeSUB00176MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,8
    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 placeboConcentrate and solvent for solution for injection/infusion
    D.8.4Route of administration of the placeboIntraosseous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prosthetic migration in uncemented total hip replacement
    E.1.1.1Medical condition in easily understood language
    micro-movements in total hip replacement
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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 is to evaluate the effect of local zoledronate on migration of an uncemented acetabular cup at 2 years postop as measured by RSA (Radiostereometric analysis) The measurement technique used will be maximum total point motion (MTPM).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to find if local treatment of the bone bed with zoledronate immediately before insertion will lead to:
    Reduced migration of an uncemented stem at 2 years postop as measured by RSA.
    Reduced migration of an uncemented stem between 3 months and 2 years postop.
    Fewer patients exhibiting radiolucent zones around the cup at 2 years postop.

    Other secondary objectives are changes in HHS and HOOS from baseline to 2 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients 50-70 years of age with osteoarthritis of the hip in need of hip replacement. Written informed consent to participate in the study is required.
    E.4Principal exclusion criteria
    • Abnormal configuration of the acetabulum or femur making implantation of the study implants unfeasible
    • Previous or present use of bisphosphonates or other antiresorptives
    • Prevalent use of other drugs, which influence bone, or use less than a year before randomization.
    ➢ Drugs with the following ATC codes will lead to exclusion of the patient
    o Antiepileptic drugs: N03AG, N03AF, N03AA, N03AB, N03AC,
    o Strontium: M05BX03
    o Denosumab: M05BX04
    o Parathyroid hormone: H05
    o Corticosteroids (with a dosage equivalent to more than 5mg prednisolone) : H02
    • Present use of nephrotoxic medication
    • Active malignant disease
    • Previous radiation therapy of the hip or pelvis
    • Metabolic disease (other than osteoporosis) affecting the skeleton
    • Rheumatic disease
    • Hypocalcemia as defined by local lab criteria (assessment is clinical routine)
    • Simultaneous bilateral surgery
    • Communication problems (drug abuse, language or behavior problems)
    • Creatinine clearance (GFR) <35 mL/min (assessment is clinical routine)
    • Expected follow-op period less than 3 years (e.g. due to uncontrolled malignancy)
    • Expected to require special postoperative surveillance due to increased surgical risk (e.g. for cardiac, psychiatric condition)
    • Participation in another clinical trial involving medication within 30 days
    E.5 End points
    E.5.1Primary end point(s)
    Differences in cup migration from baseline until 2 years as measured with radiostereometric analysis is the primary endpoint. These differences will be evaluated with parametric tests after log transformation of MTPM values.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    E.5.2Secondary end point(s)
    - Differences in migration of an uncemented stem at 2 years postop as measured by RSA (MTPM).
    - Differences in migration of an uncemented stem between 3 months and 2 years postop.
    - Differences in the frequency of radiolucent zones around the cup at 2 years postop.

    Differences in changes of HHS and HOOS from baseline to 2 years
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    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 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 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) 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.8.2.4Number of treatment arms in the trial2
    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 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
    The trial is ended when the the last patient has undergone radiographic and clinical assessment at 2 years and completed all evaluation forms.
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state60
    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)
    None
    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 Decision2016-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-29
    P. End of Trial
    P.End of Trial StatusCompleted
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