Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   40977   clinical trials with a EudraCT protocol, of which   6698   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-000552-18
    Sponsor's Protocol Code Number:1155/2018
    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:2019-10-18
    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 number2018-000552-18
    A.3Full title of the trial
    Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients
    Denosumab in der Prävention des Knochenabbaus immobilisierter Patienten auf einer Intensivstation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients
    Denosumab in der Vorbeugung des immobilisations-bedignten Knochenabbaus intensivpflichtiger Patienten
    A.4.1Sponsor's protocol code number1155/2018
    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 SponsorMedical University of 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 supportMedical University of Vienna
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Vienna
    B.5.2Functional name of contact pointClincial Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaehrigner Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004314040043330
    B.5.5Fax number004314040052810
    B.5.6E-mailpmr-office@meduniwien.ac.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 Prolia
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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 nameDenosumab
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDenosumab
    D.3.9.1CAS number 615258-40-7
    D.3.9.3Other descriptive nameImmunoglobulin G2 Human Monoclonal Antibody to RANK Ligand
    D.3.9.4EV Substance CodeSUB29173
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) 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 placeboSolution for injection/infusion
    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
    Immobilization because of aneurysmal subarachnoidal haemorrhage (aSAH) with moderate-severe neurological deficits (e.g. hemiparesis) and reduced state of consciousness – equivalent to Hunt&Hess 4-5 – at the time of admission to ICU
    Immobilisation aufgrund einer aneurysmatischen Subarachnoidalblutung mit moderaten bis schweren neurologischen Defiziten (z.B.Hemiparese) aud reduziertem Bewusstsein – äquivalent Hunt&Hess 4-5 – zum Zeitpunkt der Aufnahme auf die Intensivstation
    E.1.1.1Medical condition in easily understood language
    Immobilization because of reduced consciousness and neurological deficits because of an intracranial bleeding
    Immobilisation aufgrund von Bewusstseineintrübung und neurologischen Ausfällen bedingt durch eine Hirnblutung
    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
    twofold:
    a) to evaluate if a single administration of denosumab decreases bone resorption (CTX-1) within one month in immobilized patients
    b) to evaluate if one year of denosumab therapy has a positive effect on the immobilization-associated bone loss. (hip region) Additionally, potential changes of BTMs will be evaluated.

    Pilot study (n=14):
    evaluate if a single administration of denosumab decreases bone resorption (CTX-1) within one month in immobilized patients
    zweifach:
    a) Änderung des Serumspiegles von CTX-1 zwischen Baseline und 1 Monat nach erster Denosumab-Gabe
    b) Änderung der Knochenmineraldichte der Hüftregion ein Jahr nach erster Denosumab-Gabe

    Pilotstudie (n=14):
    Änderung des Serumspiegles von CTX-1 zwischen Baseline und 1 Monat nach Denosumab-Gabe
    E.2.2Secondary objectives of the trial
    a) Serum levels of osteocalcin (Oc), bone-spcific alkaline Phosphatase (BAP), procollagen ta) pe 1 amino-terminal propeptide (P1NP), Tartate resistante acid phosphatase (TRAP), dickkopf 1 (DKK1), sclerostin (SOST), periostin (PSTN), 24-h urine: Ca excretion one month and twelve months after 1st denosumab application
    b) BMD: T-score lumbar spine twelve months after 1st denosumab application
    c) Reasons for drop outs

    Pilot study (n=14):
    cortical thickness and density index of the proximal tibia (quantitative ultrasound) - characterization of subjects
    a) Serum piegel von Osteokalzin (Oc), knochen-spezifischer alkalischer Phosphatase (BAP), Prokollagen Typ 1 amino-terminales Propeptid (P1NP), Tartat resistente sauere Phosphatase (TRAP), Dickkopf 1 (DKK1), Sklerostin (SOST), Periostin (PSTN), 24-h Harn: Ca Ausscheidung ein Monat und 12 Monate nach erster Denosumab-Gabe
    b) KMD: T-Score der LWS 12 Monate nach erster Denosumab-Gabe
    c) Gründe für Studienabbruch

    Pilotstudie (n=14):
    Kortikale Dicke und Dichteindex an der proximalen Tibia (Quantitative Ultraschallmessung) - zur Charakterisierung des Kollektivs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women, men
    30-80 years of age
    Patients after aneurysmal subarachnoidal haemorrhage (aSAH) with moderate-severe neurological deficits (e.g. hemiparesis) and reduced state of consciousness – equivalent to Hunt&Hess 4-5 – at the time of admission to ICU
    Normal liver function
    Frauen und Männer
    30-80 Jahre
    Patienten, die aufgrund einer Hirnblutung bei Aufnahme auf der Intensivstation moderate bis schwere neurologische Defizite und eine eingeschränkte Bewusstseinslage haben (Hunt&Hess 4-5)
    Normale Leberfunktion
    E.4Principal exclusion criteria
    Patients after aneurysmal subarachnoidal haemorrhage (aSAH; Hunt&Hess 0-3)
    Patients after intracerebral bleeding
    Subjects with a history of prior solid organ transplantation
    Cancer within the previous 5 years
    Pregnancy
    Rheumatoid arthritis
    Severe renal insufficiency (CKD V)
    Intake of drugs with potential effects on BMD like lithium, estrogen-replacement therapy, selective estrogen-receptor modulators (SERMS), oral bisphosphonates in the last three months, denosumab and parenteral bisphosphonates in the last year - except medication necessary for the underlying disease
    Non-osteoporotic bone disease
    Recent fragility fracture within 6 months
    Patienten nach aneurysmatischer Subarachnoidalblutung (aSAH; Hunt&Hess 0-3)
    Patients nach intrazerebraler Blutung
    Personen nach solider Organtransplantation
    Malignom innerhalb der letzten 5 Jahre
    Schwangerschaft
    Rheumatoide Arthritis
    Schwere Niereninsuffizienz(CKD V)
    Einnahme von Medikamenten mit potentiellem Effekt auf die Knochenmineraldichte wie Lithium, Hormonersatztherapie, Selektive Östrogen-Rezeptor Modulatoren (SERMS), orale Bisphosphonate in vergangenen 3 Monaten, Denosumab und parenterale Bisphosphonates im vergangeen Jahr - ausgenommen Medikation welche aufgrund der Grunderkrankung nötig ist
    Nicht-osteoporotische Knochenerkrankung
    Fragilitätsfraktur innerhalb der letzten 6 Monate
    E.5 End points
    E.5.1Primary end point(s)
    a) Serum levels of carboxy-terminal collagen crosslinks (CTX-1) one month after first denosumab application
    b) BMD of the hip region one year after the first denosumab application

    Pilot study (n=14):
    Serum levels of carboxy-terminal collagen crosslinks (CTX-1) one month after denosumab application
    a) Serumspiegel von Carboxy-terminalen Kollagen Crosslinks (CTX-1) ein Monat nach erster Denosumab-Gabe
    b) KMD der Hüftregion of the hip region ein Jahr nach erster Denosumab-Gabe

    Pilotstudie (n=14):
    Serumspiegel von Carboxy-terminalen Kollagen Crosslinks (CTX-1) ein Monat nach Denosumab-Gabe
    E.5.1.1Timepoint(s) of evaluation of this end point
    a) CTX-1: before first denosumab application, one month after first denosumab application
    b) BMD: one month and 12 months after first denosumab application

    Pilot study (n=14):
    cortical thickness and density index of the proximal tibia (quantitative ultrasound): within one week after baseline
    a) CTX-1: vor erster Denosumab-Gabe, ein Monat nach erster Denosumab-Gabe
    b) KMD: ein Monat und 12 Monate nach erster Denosumab-Gabe

    Pilotstudie (n=14):
    CTX-1: vor Denosumab-Gabe, ein Monat nach Denosumab-Gabe
    E.5.2Secondary end point(s)
    a) Serum levels of osteocalcin (Oc), bone-spcific alkaline Phosphatase (BAP), procollagen type 1 amino-terminal propeptide (P1NP), Tartate resistante acid phosphatase (TRAP), dickkopf 1 (DKK1), sclerostin (SOST), periostin (PSTN), 24-h urine: Ca excretion one month and twelve months after 1st denosumab application
    b) BMD: T-score lumbar spine twelve months after 1st denosumab application
    c) Reasons for drop outs
    a) Serumspiegel von Osteokalzin (Oc), knochen-spezifischer alkalischer Phosphatase (BAP), Prokollagen Typ 1 amino-terminales Propeptid (P1NP), Tartat resistente sauere Phosphatase (TRAP), Dickkopf 1 (DKK1), Sklerostin (SOST), Periostin (PSTN), 24-h Harn: Ca Ausscheidung ein Monat und 12 Monate nach erster Denosumab-Gabe
    b) KMD: T-Score der LWS 12 Monate nach erster Denosumab-Gabe
    c) Gründe für Studienabbruch

    Pilotstudie (n=14):
    Kortikale Dicke und Dichteindex an der proximalen Tibia (Quantitative Ultraschallmessung) - innerhalb einer Woche nach Baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    Biochemical parameters: before first denosumab application, one month, 6 and 12 months after first denosumab application
    BMD: one month and 12 months after first denosumab application
    Reasons for drop outs: on occasion
    Laborparameter: vor erster Denosumab-Gabe, ein Monat, 6 und 12 Monate nach erster Denosumab-Gabe
    KMD: ein Monat und 12 Monate nach erster Denosumab-Gabe
    Gründe für Studienabbruch: anlassbezogen
    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 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) 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 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 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2019-10-18. Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with reduced state of conciousness after aneurysmal subarachnoidal haemorrhage
    Patienten mit reduzierter Bewusstseinslage nach Subarachnoidalblutung
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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
    Keine
    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 Decision2019-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-25
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA