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    Summary
    EudraCT Number:2022-001750-29
    Sponsor's Protocol Code Number:ZORRO
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-29
    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 ConcernedAustria - BASG
    A.2EudraCT number2022-001750-29
    A.3Full title of the trial
    Influence of zoledronic acid on healing after arthroscopic repair of chronic
    rotator cuff lesions - A prospective, randomized, placebo-controlled phase II trial
    Einfluss von Zoledronsäure auf die Heilung nach arthroskopischer
    Rekonstruktion chronischer Rotatorenmanschettenrupturen - Eine
    prospektive, randomisierte, Placebo-kontrollierte Phase II Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of an anti-osteoporotic drug on healing after surgical repair of chronic rotator cuff lesions of the shoulder
    Einfluss eines anti-osteoporotischen Medikaments auf die Heilung
    chronischer Rotatorenmanschettenrupture der Schulter
    A.3.2Name or abbreviated title of the trial where available
    Zoledronic acid in chronic rotator cuff lesions
    Zoledronsäure bei chronischen Rotatorenmanschettenrupturen
    A.4.1Sponsor's protocol code numberZORRO
    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 SponsorAUVA Trauma Center Vienna
    B.1.3.4CountryAustria
    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 supportAUVA (Austrian Accident Insurance Institute)Trauma Center
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAUVA Trauma Center Vienna
    B.5.2Functional name of contact pointJakob Schanda PD DDr.
    B.5.3 Address:
    B.5.3.1Street AddressKundratstrasse 37
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1120
    B.5.3.4CountryAustria
    B.5.4Telephone numberÖster5939345201
    B.5.5Fax number5939345358
    B.5.6E-mailjakob.schanda@auva.at
    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 Aclasta (Zoledronic Acid)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameAclasta
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot available
    D.3.9.1CAS number 165800-06-6
    D.3.9.2Current sponsor codenot available
    D.3.9.3Other descriptive nameZOLEDRONIC ACID MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21645
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,05 mg/ml
    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 placeboInfusion (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    INFLUENCE OF ZOLEDRONIC ACID ON HEALING AFTER ARTHROSCOPIC REPAIR OF CHRONIC ROTATOR CUFF LESIONS
    EINFLUSS VON ZOLEDRONSÄURE AUF DIE HEILUNG NACH ARTHROSKOPISCHER REPARATUR CHRONISCHER ROTATORENMANSCHETTENLÄSIONEN
    E.1.1.1Medical condition in easily understood language
    Influence of zoledronic acid on healing after surgery from a tearing of tendons and muscles in the shoulder
    Einfluss von Zoledronsäure auf die Heilung nach einer Operation von einem Abriss von sehnen und Muskeln in der Schulter
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    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 evaluate the influence of an adjuvant, intravenous therapy with zoledronic acid (single dose) on healing after arthroscopic repair of chronic rotator cuff tears.
    Beurteilung des Einflusses einer adjuvanten, intravenösen Therapie mit Zoledronsäure (Einzeldosis) auf die Heilung nach arthroskopischer Reparatur von chronischen Rotatorenmanschettenrissen.
    E.2.2Secondary objectives of the trial
    not applicable
    nicht zutreffe
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age between 50 and 70 years
    • Magnetic resonance imaging verified rotator cuff tear (done within 6 month before surgery)
    • Rupture size with a maximum diameter of 3 cm
    • Willingness to participate in the study
    • Willingness to participate in a unified physiotherapy with use of a shoulder abduction pad for four weeks postoperatively
    • Alter zwischen 50 und 70 Jahren
    • Magnetresonanztomographie verifizierter Rotatorenmanschettenriss (binnen 6 Monaten vor OP durchgeführt)
    • Bruchgröße mit einem maximalen Durchmesser von 3 cm
    • Bereitschaft zur Teilnahme an der Studie
    • Bereitschaft zur Teilnahme an einer einheitlichen Physiotherapie mit Verwendung eines Schulterabduktionspolsters für vier Wochen postoperativ
    E.4Principal exclusion criteria
    • Patients younger than 50 or older than 70 years of age
    • Pregnancy
    • Known allergy to zoledronic acid or other components of the medicinal product
    • Previous fracture of the affected shoulder
    • Previous surgery of the affected shoulder
    • Previous or existing bacterial infection of the affected shoulder
    • Rupture of more than two tendons in the affected shoulder (massive rotator cuff tear)
    • Isolated subscapularis tendon tear
    • Presence of glenohumeral osteoarthritis (Hamada type 3 or higher)
    • Diabetes mellitus (fasting glucose ≥ 126 mg/dl, HbA1C ≥ 6.5%)
    • Malignant tumor disease
    • Pathological dental status
    • Known disease that interferes with bone metabolism
    • Concomitant diseases that do not permit general anesthesia
    • Previous therapy with anti-osteoporotic drugs (bisphosphonates, denosumab, teriparatide)
    • Epilepsy
    • Claustrophobia
    • Chronic alcohol abuse
    • Drug abuse
    • Patienten unter 50 Jahren oder älter als 70 Jahre
    • Schwangerschaft
    • Bekannte Allergie gegen Zoledronsäure oder andere Bestandteile des Arzneimittels
    • Vorherige Fraktur der betroffenen Schulter
    • Vorherige Operation der betroffenen Schulter
    • Frühere oder bestehende bakterielle Infektion der betroffenen Schulter
    •• Ruptur von mehr als zwei Sehnen in der betroffenen Schulter (massiver Rotatorenmanschettenriss)
    • Isolierter Subscapularissehnenriss
    • Vorhandensein von glenohumeraler Osteoarthritis (Hamada Typ 3 oder höher)
    • Diabetes mellitus (Nüchternglukose ≥ 126 mg/dl, HbA1C ≥ 6,5%)• Bösartige Tumorerkrankung
    • Pathologischer Zahnstatus
    • Bekannte Krankheit, die den Knochenstoffwechsel stört
    • Begleiterkrankungen, die keine Vollnarkose zulassen
    • Vorherige Therapie mit antiosteoporotischen Medikamenten (Bisphosphonate, Denosumab, Teriparatid)
    - Epilepsie
    • Klaustrophobie
    • Chronischer Alkoholmissbrauch
    • Drogenmissbrauch
    E.5 End points
    E.5.1Primary end point(s)
    investigation of zoledronic acid on tendon integrity via magnetic resonance imaging at six months , twelve months , twentyfour and sixty months after arthroscopic repair of chronic rotator cuff lesions.
    Untersuchung der Zoledronsäure auf die Sehnenintegrität mittels Magnetresonanztomographie nach sechs Monaten, zwölf, vierundzwanzig sowie sechzig Monaten nach arthroskopischer Reparatur chronischer Rotatorenmanschettenläsionen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    six months, twelve months, 24 and 60 months after arthroscopic repair of chronic rotator cuff lesions.
    6, 12, 24 sowie 60 Monate nach Operation der gerissenen Rotatorenmanschette
    E.5.2Secondary end point(s)
    Examination of bone metabolism, micro-RNA , specific clinical test concerning shoulder function as well as collection of functional questionaires to investigate the muscular regeneration by zoledronic acid
    Untersuchung des Knochenstoffwechsels, micro-RNA, spezifischer klinischer Test zur Schulterfunktion sowie Sammlung funktioneller Fragebögen zur Untersuchung der Muskelregeneration durch Zoledronsäure
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 day, 4 week, 3 months, 6 months , 12 months, 24 months and 60 months after arthroscopic repair of chronic rotator cuff lesions.

    An interim analysis is planned after all 80 patients have completed the “3 month postoperative” visit. This will be expected between Q1/ 2025 and Q4/ 2025.
    2 Tage, 4 Wochen, 3 Monate, 6 Monate, 12 Monate, 24 Monate und 60 Monate nach arthroskopischer Reparatur von chronischen Rotatorenmanschettenläsionen.

    Nachdem alle 80 Patienten die "3-Monats-Postoperative" Visite absolviert haben, ist die Durchführung einer Interimsanalyse" geplant . Dies wird zwischen dem 1. und 4. Quartal 2025 erwartet.
    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 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
    LVLS
    last visit of last patient/letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state80
    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)
    not applicable,
    After completion of the study participation, the patient receives, if necessary, treatment within the usual routine
    nicht zutreffend,
    Nach Beendigung der Studienteilnahme erhält der Patient, falls erforderlich, eine Behandlung im Rahmen der üblichen Routine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Ludwig Boltzmann Institute for Traumatology
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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