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    Summary
    EudraCT Number:2019-000757-31
    Sponsor's Protocol Code Number:2018/728
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-14
    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 ConcernedNorway - NOMA
    A.2EudraCT number2019-000757-31
    A.3Full title of the trial
    A RANDOMIZED PLACEBO CONTROLLED TRIAL TESTING THE EFFECTS OF ZOLEDRONIC ACID ON HIP OSTEOARTHRITIS
    En randomisert placebo kontrollert studie som tester effekten av zoledronsyre på hofteartrose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A RANDOMIZED PLACEBO CONTROLLED TRIAL TESTING THE EFFECTS OF ZOLEDRONIC ACID ON HIP OSTEOARTHRITIS
    En randomisert placebo kontrollert studie som tester effekten av zoledronsyre på slitasjegikt i hofte
    A.4.1Sponsor's protocol code number2018/728
    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 SponsorMartina Hansens Hospital
    B.1.3.4CountryNorway
    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 supportSouth east health region Norway
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMartina Hansens Hospital
    B.5.2Functional name of contact pointMehran Karimzadeh
    B.5.3 Address:
    B.5.3.1Street AddressDønskiveien 8
    B.5.3.2Town/ cityGjettum
    B.5.3.3Post code1346
    B.5.3.4CountryNorway
    B.5.4Telephone number+4741430288
    B.5.6E-mailmehran.karimzadeh@mhh.no
    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 Zoledronic Acid (Fresenius Kabi)
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 nameZoledronic Acid
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Investigated disease is osteoarthritis of the hip with concurrent Bone marrow lesions
    Undersøkelse av pasienter med hofteartrose og sammenfallende benmargslesjoner
    E.1.1.1Medical condition in easily understood language
    investigation of patients with hip osteoarthrits and bone marrow oedema on MRI
    Undersøkelse av pasienter med hofteslitasje og benmargsforandringer på MR
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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
    To test the effect on pain in hip OA by two doses of ZA given 3 months apart, 12 months after the first infusion
    å teste effekten på smerter i hofte artrose med to doser ZA gitt med 3 måneders mellomrom, 12 måneder etter den første infusjonen
    E.2.2Secondary objectives of the trial
    1. To test the effect on pain in hip OA by two doses of ZA given 3 months apart, 3 and 6 months after the first infusion
    2. To test the effect on function and activity in hip OA by two doses of ZA given 3 months apart, 3, 6 and 12 months after the first infusion measured with PROMs.
    3. To test the effect on function in hip OA by two doses of ZA given 3 months apart, 3, 6 and 12 months after the first infusion measured with functional tests.
    4. To test the effect on QoL in hip OA by two doses of ZA given 3 months apart, 3, 6 and 12 months after the first infusion measured with PROMs .
    5. To test the effect on the use of analgetics (NSAID, Paracetamol and opiates) by two doses of ZA given 3 months apart, 12 months after the first infusion
    6. Safety in hip OA treated with two doses of ZA given 3 months apart measured 3, 6 and 12 months after the first infusion
    7. To investigate the effects of zoledronic acid on progress of OA in the hip

    continue next box....
    8. To investigate effects of zoledronic acid on bone turnover and angiogenesis in BMLs associated with hip OA
    9. To test the hypothesis that patients with OA show impaired bone material properties.
    10. To test the hypothesis that patients with hip OA treated with two doses of Zoledronic acid given 3 months apart have reduced risk of implant surgery 12 months after the first infusjon compared to placebo group



    1.å teste effekten på smerter i hofte artrose med to doser ZA gitt med 3 måneders mellomrom, 3 og 6 måneder etter den første infusjonen
    2. å teste effekten på funksjon og aktivitet i hofte-artrose med to doser ZA gitt med 3 måneders mellomrom, 3, 6 og 12 måneder etter den første infusjonen målt med PROM.
    3. Få teste effekten på funksjonen i hofte artrose med to doser ZA gitt med 3 måneders mellomrom, 3, 6 og 12 måneder etter den første infusjonen målt med funksjonelle tester.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 50-80
    • Continuous worsening of hip pain with an onset of minimum 3 months
    • Hip Pain intensity >40mm on a visual analogue scale (VAS) ranging from 0 (no pain) to 100mm (maximal pain) during weight bearing for the last 7 days
    • HHS < 65 (Harris Hip Score)
    • Hip OA fulfilling the ACR criteria [33]
    • Hip MRI scan showing large (>1 cm diameter) Bone Marrow lesions (BMLs)
    • Willing and able to consent and comply with the study protocol
    • Alder 50-80
    • Kontinuerlig forverring av hoftesmerter med begynnelse på minimum 3 måneder
    • Hoftesmerteintensitet> 40 mm i en visuell analog skala (VAS) fra 0 (ingen smerter) til 100 mm (maksimal smerte) under vektbæring de siste 7 dagene
    • HHS <65 (Harris Hip Score)
    • Hip OA som oppfyller ACR-kriteriene
    • MRI-skanning i hoften som viser store (> 1 cm diameter) benmargslesjoner (BML)
    • Villig og i stand til å samtykke og overholde studieprotokollen
    E.4Principal exclusion criteria
    • eGFR < 35 ml/min or hypocalcemia
    • Exposure to any treatment affecting bone other than Ca+D ( bisphosphonates, Denosumab or continuous treatment of prednisolone)
    • Diseases affecting bone and joints (i.e inflammatory joint diseases, avascular necrosis, primary bone cancer or skeletal metastases)
    • Severe vitamin D deficiency (S-25(OH)D < 25 nmol/l) has to be supplemented with Ca+D before zoledronic acid infusion
    • Ipsilateral knee prosthesis
    • Contralateral hip prosthesis
    • Women of child bearing potential (WOCBP). Female participants must be in a postmenopausal state or permanent sterile.
    • Hypersensitivity or previous allergic reaction to ZA or other bisphosphonates.
    • Hypersensitivity or previous allergic reaction to Calcigran Forte or Prednisolone
    eGFR <35 ml / min eller hypokalsemi
    • Eksponering for enhver behandling som påvirker bein annet enn Ca + D
    • Sykdommer som påvirker bein og ledd (dvs. betennelsesleddsykdommer, avaskulær nekrose, primær beinkreft eller skjelettmetastaser)
    • Alvorlig vitamin D-mangel (S-25 (OH) D <25 nmol / l) må normaliseres med Ca + D før zoledronsyre-infusjon
    • Ipsilateral kneprotese
    • Kontralateral hofteprotese
    • Kvinner i fertil alder (WOCBP). Kvinnelige deltakere må være i postmenopausal tilstand eller permanent steril.
    • Overfølsomhet eller tidligere allergisk reaksjon på ZA eller andre bisfosfonater.
    • Overfølsomhet eller tidligere allergisk reaksjon mot Calcigran Forte eller Prednisolone
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in joint pain by VAS from baseline to 12 months follow up, in the intervention group compared to the placebo group
    1. Gjennomsnittlig endring i leddsmerter ved VAS fra baseline til 12 måneder oppfølging, i intervensjonsgruppen sammenlignet med placebogruppen
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mnd
    E.5.2Secondary end point(s)
    1. Mean change in joint pain by VAS from baseline to 3 and 6 months follow up, in the intervention group compared to the placebo group
    2.
    a. Mean change in function and activity score (HOOS) from baseline to 3, 6 and 12 months follow up, in the intervention group compared to the placebo group
    b. Mean change in function and activity score (HHS) from baseline to 3, 6 and 12 months follow up, in the intervention group compared to the placebo group
    3.
    a. Mean change in 40mWT (seconds) from baseline to 3, 6 and 12 months follow up, in intervention group compared to placebo group
    b. Mean change in SCT (seconds) from baseline to 3, 6 and 12 months follow up, in intervention group compared to placebo group
    c. Mean change in 30CST (repetitions) from baseline to 3, 6 and 12 months follow up, in intervention group compared to placebo group
    4. Mean change in QoL (EQ-5D) from baseline to 3, 6 and 12 months follow up, in the intervention group compared to the placebo group
    5. Change in mean number of doses of Paracetamol, NSAID and/or opiates per week in each group during the last month compared to baseline at 12 months follow up.
    6. Number of AE/SAE and AR/SAR/SUSAR in the intervention group compared to placebo group 12 months after first infusion.
    7. Change in joint space narrowing, cartilage quality and amount of synovial fluid from baseline to 12 months follow up seen on MRI T2 Mapping, compared to the placebo group.
    8. Changes in bone turnover and vascularization in BMLs after treatment with zoledronic acid seen with histomorphometry. A comparison between patients in the treatment and placebo group, that end up with joint implant surgery.
    9. Changes in bone material properties by impact microindentation of tibial bone before and after treatment with zoledronic acid compared to the placebo group
    10. Percentage of participants treated with implant surgery of the affected hip in the treatment group compared to placebo group 12 months after the first infusion.
    1. Gjennomsnittlig endring i leddsmerter ved VAS fra baseline til 3 og 6 måneder oppfølging, i intervensjonsgruppen sammenlignet med placebogruppen
    2. a.
    a. Gjennomsnittlig endring i funksjons- og aktivitetscore (HOOS) fra baseline til 3, 6 og 12 måneder oppfølging, i intervensjonsgruppen sammenlignet med placebogruppen
    b. Gjennomsnittlig endring i funksjons- og aktivitetscore (HHS) fra baseline til 3, 6 og 12 måneder oppfølging, i intervensjonsgruppen sammenlignet med placebogruppen
    3. a
    a. Gjennomsnittlig endring i 40 mWT (sekunder) fra baseline til 3, 6 og 12 måneder oppfølging, i intervensjonsgruppe sammenlignet med placebogruppe
    b. Gjennomsnittlig endring i SCT (sekunder) fra baseline til 3, 6 og 12 måneder oppfølging, i intervensjonsgruppe sammenlignet med placebogruppe
    c. Gjennomsnittlig endring i 30CST (repetisjoner) fra baseline til 3, 6 og 12 måneder oppfølging, i intervensjonsgruppe sammenlignet med placebogruppe
    4. Gjennomsnittlig endring i QoL (EQ-5D) fra baseline til 3, 6 og 12 måneder oppfølging, i intervensjonsgruppen sammenlignet med placebogruppen
    5. Endring i gjennomsnittlig antall doser Paracetamol, NSAID og / eller opiater per uke i hver gruppe i løpet av den siste måneden sammenlignet med baseline etter 12 måneders oppfølging.
    6. Antall AE / SAE og AR / SAR / SUSAR i intervensjonsgruppen sammenlignet med placebogruppe etter 12 mnd.
    7. Endring i innsnevring i leddspalte, bruskkvalitet og mengde synovialvæske fra baseline til 12 måneder oppfølging sett på MRI T2 kartlegging, sammenlignet med placebogruppen.
    8. Endringer i beinomsetning og vaskularisering i BML etter behandling med zoledronsyre sett med histomorfometri. En sammenligning mellom pasienter i behandlingsgruppen og placebogruppen, som ender med leddimplantatkirurgi.
    9. Endringer i benmaterialegenskaper ved påvirkning av mikroindikasjon av tibialben før og etter behandling med zoledronsyre sammenlignet med placebogruppen
    10. Prosentandel av deltakerne som ble behandlet med implantatkirurgi av den berørte hoften i behandlingsgruppen sammenlignet med placebogruppe 12 måneder etter den første infusjonen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months
    3, 6 og 12 mnd
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state70
    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)
    Patients will be offered continued treatment if they want it. If they have insufficient effect surgery will be offered.
    Patients will be offered to join an open label extension study
    Pasienter som ønsker videre behandling vil bli tilbudt dette. Har de dårlig effekt kan kirurgi tilbys.
    Pasienter vil bli tilbudt å være med i en open label extension studie
    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 Decision2019-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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