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    Summary
    EudraCT Number:2011-001481-18
    Sponsor's Protocol Code Number:6925
    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:2011-08-19
    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 number2011-001481-18
    A.3Full title of the trial
    Uncemented total hip implant and subcutaneous injection of Denosumab for patients with osteoarthritis of the hip. A randomised double blind placebo controlled study on the effects on bone evaluated with DXA, PET/CT, and biochemical markers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Uncemented total hip implant and subcutaneous injection of Denosumab for patients with degenerative joint disease of the hip. A randomised double blind placebo controlled study on the effects on bone evaluated with bone densitometry, uptake of Fluoride isotop measure with Positron Emission Tomography and Computed Tomography, and blood samples analyzed for bone turnover.
    A.3.2Name or abbreviated title of the trial where available
    DATA
    A.4.1Sponsor's protocol code number6925
    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 SponsorUppsala University Hospital
    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 supportSkofonden
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportEndoklinikk
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUppsala University
    B.5.2Functional name of contact pointHans Mallmin
    B.5.3 Address:
    B.5.3.1Street AddressDept of Orthopedics, University Hospital
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post codeS-75185
    B.5.3.4CountrySweden
    B.5.4Telephone number46186114478
    B.5.5Fax number4618509427
    B.5.6E-mailhans.mallmin@akademiska.se
    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 Prolia
    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 nameProlia
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    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) 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) Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    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
    Patients with osteoarthritis of the hip treated with an uncemented total hip arthroplasty. This procedure is accompanied with an increased risk for loss of bone adjacent to the implants
    E.1.1.1Medical condition in easily understood language
    Patients with osteoarthritis of the hip treated with an uncemented total hip arthroplasty. This procedure is accompanied with an increased risk for loss of bone adjacent to the implants
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 study the effect of Denosumab on Bone Mineral Density, Standardised Uptake Value and bone metabolism in patients with total hip arthroplasty. The primary hypothesis is to demonstrate that Denosumab is superior to placebo.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to:
    • evaluate the safety and tolerability of Denosumab in patients with total hip arthroplasty
    • evaluate quality of life after treatment with Denosumab in patients with total hip arthroplasty
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patients must fulfil the following criterias to included

    1. Male or female patients patients 35-65 years of age with an unilateral OAH requiring a THA and a healthy contralateral hip,
    2. Body weight <110 kg or BMI <35 kg/m2
    3. Living in the Uppsala County.
    4. The eligible patients should have been given oral information, a written Patient information and signed an Informed Consent
    Demographic history, age, sex, height and weight, medical history, physical examination should be recorded and checked for inclusion as well as exclusion criterias.
    E.4Principal exclusion criteria
    The presence of any of the following criteria will exclude the patient from participating in the study:

    1. on or previously have had bone-specific treatment, eg bisphophonates, raloxiphene, parathyroid hormone, strontium ranelate, during the last five years
    2. patients on systemical corticosteroid for more than 3 months should not be considered..
    3. patients with diagnosed malignant disease during the last five years or known to have metastasis from malignant disease should be excluded.
    4. Patients with renal insufficiency and a se-creatinine-clearance <35ml/min, calcultated according to Cockcroft-Gault, must not be included in the study.
    5. Patients with compromised general conditions and an American Society of Anesthesiologists, ASA-score >31 should not be regarded eligible.
    6. Patients with known drug or alcohol abuse or regarded as socially dysfunctional, as judged by the investigator, should not be considered for the study.
    7. Pregnant women or women planning for pregnancy or fertile women (premenopausal) without contraceptives should not be accepted for the study.
    8. Patients that have been exposed frequently and/or have had large irradiation doses, as jugded by the investigator, must not be included in the study.
    9. Enrolled in either another investigational drug study, in another investigational device study, or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
    10. Any condition or laboratory findings which in the opinion of the Investigator makes the patient unsuitable for inclusion
    E.5 End points
    E.5.1Primary end point(s)
    1. BMD, g/cm2, adjacent to the femur implant, Gruen zone 7, and the sum for all Gruen zones after 12 months
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    E.5.2Secondary end point(s)
    1. Fluoride isotope uptake, measured as Standardized Uptake Values, adjacent to the femoral stem, 3 and 6 months after surgery and longitudinal changes during the period after surgery.
    2. The study drug’s effects on SUV measured with PET/CT adjacent to the acetabular cup after 3 and 6 months and longitudinal changes during the period after surgery.
    3. The study drugs effect on BMD adjacent to the acetabular cup during the follow up period, ie after 3,6, 12 and 24 months
    4. The study drug’s effects on biochemical markers for bone turnover and the relation to PET and BMD findings at the proximal femur and acetabulum during the follow up period, ie after 3,6, 12 and 24 months
    5. The study drug’s effects on BMD at the lumbar spine and at the contra lateral hip after surgical treatment with an uncemented THA after 12 months (and 24 and 60 months)
    6. The study drug’s effects on biochemical markers for bone turnover and the relation to PET and BMD findings at anatomical sites not exposed to surgery, ie the lumbar spine and the contra lateral hip after 3 and 6 months
    7. The natural course of an uncemented THA on SUV measured with PET, ie the placebo group after 3 and 6 months (and 24 months)
    8. The natural course of an uncemented THA on biochemical markers, ie the placebo group after 3, 6 and 12 months.
    9. The study drug’s effect on SUV at the lumbar spine and at the contra lateral hip after surgical treatment with an uncemented THA after 3 and 6 months
    10. Patients Quality of Life, measured by Harris Hip score and EQ-5D questionnaires.
    11. To evaluate incidence and severity of adverse events during the study period
    E.5.2.1Timepoint(s) of evaluation of this end point
    3,6,12,24 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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 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 No
    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
    Last patient Last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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.1.1.1In 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: 64
    F.1.3Elderly (>=65 years) No
    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 Yes
    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 state64
    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)
    Long-term of follow-up 2 years. Otherwise no excepetion from the normal way of handling of these patients.
    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 Decision2011-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-30
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