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    Summary
    EudraCT Number:2016-005244-42
    Sponsor's Protocol Code Number:20159990
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-005244-42
    A.3Full title of the trial
    An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Rich Tumors of Bone.
    Open label, multicenter, fase 2 studie naar denosumab bij patienten met reuscelrijke tumoren van het bot.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Denosumab in patients with giant cell rich tumors of bone.
    Denosumab in patienten met reuscelrijke tumoren van het bot.
    A.3.2Name or abbreviated title of the trial where available
    NGCTB
    A.4.1Sponsor's protocol code number20159990
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportAmgen
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointResearch secretary
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 RC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310715261093
    B.5.6E-mailw.van_andel@lumc.nl
    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 Xgeva
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen
    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.3.4Pharmaceutical form Solution for injection
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Aneurysmal bone cysts, giant cell granuloma, other giant cell rich lesions (primary bone, non-malignant)
    Aneurysmatische botcysten, reuscelgranulomen, andere reuscelrijke lesies (primair uitgaande van bot, niet maligne)
    E.1.1.1Medical condition in easily understood language
    Aneurysmal bone cysts, giant cell granuloma, other benign giant cell rich lesions of bone
    Aneurysmatische botcysten, reuscelgranulomen, andere goedaardige reuscelrijke lesies van het bot
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10018252
    E.1.2Term Giant cell granuloma peripheral
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004430
    E.1.2Term Benign osteoblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008686
    E.1.2Term Chondroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008733
    E.1.2Term Chondromyxoid fibroma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002362
    E.1.2Term Aneurysmal bone cyst
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Subjects with salvageable giant cell rich tumors:
    - To evaluate subjects who do not require surgery during the study
    - To evaluate subjects who are able to undergo a less morbid surgical procedure compared with the planned surgical procedure at baseline during the study

    Subjects with unsalvageable giant cell rich tumors (combined objective):
    - To evaluate disease control:
    o Radiological response assessed by combined RECIST, PET, inverse Choi when available AND/OR
    o No progression at 1 year (based on disease assessment)
    - Stable pain score, defined as ≤ 1 point increase on ‘worst pain’ question in Brief Pain Inventory - short form (BPI-SF)
    Patienten met operabele reuscelrijke tumoren:
    - Evalueren van patienten bij wie operatie achterwege gelaten kan worden gedurende de studie
    - Evalueren van patienten welke minder uitgebreide chirurgie kunnen ondergaan dan initieel gepland

    Patienten met inoperabele reuscelrijke tumoren
    - Evalueren van controle van de ziekte
    o Radiologische respons bepaald middels gecombineerd RECIST, PET, inverse Choi criteria waar beschikbaar EN/OF
    o Aanwezigheid progressie van 1 jaar (bepaald middels ziekte evaluatie arts)
    - Stabiele pijnscore, gedefinieerd als ≤ 1 punt toename op de 'ergste pijn' vraag in de Korte Pijn Vragenlijst (BPI-SF)
    E.2.2Secondary objectives of the trial
    - To evaluate the safety and tolerability of denosumab in subjects with giant cell rich tumors
    - To evaluate the proportion of recurrences after denosumab followed by surgery
    - To evaluate symptomatic improvement after denosumab in subjects with giant cell rich tumors
    - To evaluate time to surgery (for subjects with salvageable disease), time to recurrence after surgery, progression free survival
    Secundair
    - Evalueren van veiligheid en tolerabiliteit van denosumab in patiënten met reuscelrijke tumoren
    - Evalueren van hoeveelheid recidieven na behandeling met denosumab gevolgd door chirurgie
    - Evalueren van symptomatische verbetering na denosumab in patiënten met reuscelrijke tumoren
    - Evalueren van 'tijd tot chirurgie'(voor patiënten met operabele ziekte), tijd tot recidief na chirurgie, en progressie vrije overleving
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational research
    - Translational studies. Systematic analysis of pathologic and molecular markers on tumor material, including evaluation of pathological response for subjects undergoing surgery
    Translationeel onderzoek
    - Systematische analyse van pathologische en moleculaire markers op tumor materiaal, inclusief evaluatie van pathologische respons na tumor resectie voor patiënten met operabele ziekte
    E.3Principal inclusion criteria
    The population will consist of patients with the following tumor types:
    - Pathologically proven giant cell rich tumor
    • ABC
    • GCG
    • Other giant cell rich lesions (primary bone, non-malignant, pathology and radiology to be reviewed during multidisciplinary meeting LUMC)

    - Patients with surgically unsalvageable disease (e.g., sacral, spinal giant cell rich tumors, or multiple lesions including pulmonary metastases) OR patients whose planned surgery includes joint resection, limb amputation, hemipelvectomy or surgical procedure resulting in severe morbidity
    - Measurable evidence of active disease within 1 year before study enrollment
    - Albumin-adjusted serum calcium level ≥ 2.0 mmol/L (8.0 mg/dL)
    - Aged 18 years and up and skeletally mature
    - ECOG performance status 0, 1 or 2
    - Written signed informed consent
    De volgende tumortypes worden geïncludeerd:
    - Aneurysmatische botcysten
    - Reuscelgranulomen
    - Overige benigne, reuscelrijke lesies van het bot (pathologie en radiologie worden geëvalueerd tijdens multidisciplinair overleg in het LUMC)

    - Patiënten met niet operabele ziekte (b.v. sacraal of spinaal gelokaliseerd, of multipele laesies inclusief pulmonale metastasen) OF patiënten voor wie geplande chirurgie gewrichtsresectie, amputatie van ledematen, hemipelvectomie of andere ernstig invaliderende chirurgie omvat
    - Bewijs van ziekteactiviteit in het jaar voor studiedeelname
    - Gecorrigeerd serum calcium ≥ 2.0 mmol/L (8.0 mg/dL)
    - Leeftijd ≥ 18 jaar en een volwassen skeletleeftijd
    - ECOG performance status 0, 1 of 2
    - Schriftelijk toestemming gegeven
    E.4Principal exclusion criteria
    - Known or suspected current diagnosis of classic GCTB
    - Known or suspected current diagnosis of underlying malignancy including but not limited to high-grade sarcoma, osteosarcoma, fibrosarcoma, malignant giant cell sarcoma
    - Known or suspected current diagnosis of brown cell tumor of hyperparathyroidism, Paget’s disease or cherubism
    - Known or suspected current diagnosis of primary soft tissue tumor with invasion of the bone
    - Known diagnosis of other malignancy within the past 5 years (patients with definitively treated basal cell carcinoma and cervical carcinoma in situ are permitted)
    - Previous treatment with denosumab (with the exception of patients eligible for re-treatment with denosumab after completing this study)
    - Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
    - Active dental or jaw condition which requires oral surgery, including tooth extraction
    - Non-healed dental/oral surgery
    - Planned invasive dental procedure for the course of the study
    - Known hypersensitivity to denosumab
    - Known hypersensitivity to products to be administered during the study (calcium and/or vitamin D)
    - Currently receiving other specific treatment for giant cell rich tumors of bone (e.g., radiation, chemotherapy or embolization)
    - Concurrent bisphosphonate treatment
    - Major surgery less than 4 weeks prior to start of treatment
    - Treatment with other investigational device or drug 30 days prior to study enrollment
    - Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before study enrollment
    - Patient is pregnant or breast feeding, or planning to become pregnant within 5 months after the EOT visit
    - Patient, or partner of patient, of child bearing potential is not willing to use a highly effective method of contraception during treatment and for 5 months after the EOT visit
    - Patient has any kind of disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures
    - Bewezen of verdenking op actuele diagnose klassieke reusceltumor van het bot
    - Bewezen of verdenking op actuele diagnose van onderliggende maligniteit, inclusief maar niet gelimiteerd tot hooggradig sarcoom, osteosarcoom, fibrosarcoom, maligne reuscelsarcoom
    - Bewezen of verdenking op actuele diagnose van ‘bruine tumor’ met hyperparathyreoïdie, ziekte van Paget of cherubisme
    - Bewezen of verdenking op actuele diagnose van primaire weke delen tumor met invasie in het bot
    - Bewezen of verdenking op andere maligniteit in de 5 jaar voor studiedeelname (patiënten met behandeld basaalcelcarcinoom en cervixcarcinoom in situ mogen wel deelnemen)
    - Eerdere behandeling met denosumab (uitgezonderd patiënten welke in aanmerking komen voor herstart van denosumab na afronden van deze studie)
    - Voorgeschiedenis of actuele diagnose osteonecrose of osteomyelitis van de kaak
    - Actieve tandheelkundige of kaakaandoening waarvoor orale chirurgie, inclusief gebitsextractie, noodzakelijk is
    - Niet volledig geheelde tandheelkundige of orale chirurgie
    - Geplande invasieve tandheelkundige procedure gedurende het beloop van de studie
    - Bekende hypersensitiviteit voor denosumab
    - Bekende hypersensitiviteit voor medicamenten welke tijdens de studie toegediend worden (calcium en/of vitamine D preparaten)
    - Gelijktijdig ondergaan van andere behandeling gericht op reuscelrijke tumoren van het bot (b.v. radiotherapie, chemotherapie of embolisatie)
    - Gelijktijdige behandeling met bisfosfonaten
    - Majeure chirurgie binnen 4 weken voor start van de studiebehandeling
    - Behandeling met andere geneesmiddelen of devices in het kader van wetenschappelijk onderzoek in de 30 dagen voor enrollment in de studie
    - Onstabiele systemische aandoening inclusief actieve infectie, ongecontroleerde hypertensie, onstabiele angina pectoris, hartfalen of myocardinfarct binnen 6 maanden voor enrollment in de studie
    - Patiënt is zwanger of geeft borstvoeding, of voorziet binnen 5 maanden na het einde studie bezoek zwanger te raken
    - Vrouwelijke vruchtbare patiënt of vruchtbare partner van patient, welke niet bereid is om een zeer effectieve methode van anticonceptie toe te passen gedurende de studiedeelname en tot 5 maanden na het einde studie bezoek
    - Patiënt heeft een aandoening die het geven van schriftelijke toestemming en/of het opvolgen van de studieprocedures onmogelijk maakt
    E.5 End points
    E.5.1Primary end point(s)
    Subjects with salvageable giant cell rich tumors:
    1. The proportion of subjects who do not require surgery during the study
    2. The proportion of subjects undergoing the planned versus performed type of surgery during the study

    Subjects with unsalvageable giant cell rich tumors (combined endpoint):
    3. Disease control:
    3.1 Radiological response assessed by combined RECIST, PET, inverse Choi when available AND/OR
    3.2 No progression at 1 year (based on disease assessment)
    4. Stable pain score, defined as ≤ 1 point increase on ‘worst pain’ question in BPI-SF
    Patiënten met operabele reuscelrijke tumoren:
    1. Proportie van patiënten bij wie operatie achterwege gelaten kan worden tijdens de studie
    2. Proportie van patiënten welke minder uitgebreide chirurgie kunnen ondergaan dan initieel gepland

    Patiënten met inoperabele reuscelrijke tumoren (gecombineerd eindpunt)
    3. Ziekte controle
    3.1 Radiologische respons bepaald middels gecombineerde RECIST, PET, inverse Choi criteria waar beschikbaar EN/OF
    3.2 Geen progressie na 1 jaar (bepaald middels ziekte evaluatie arts)
    4. Stabiele pijnscore, gedefinieerd als ≤ 1 punt toename op de 'ergste pijn' vraag in de Korte Pijn Vragenlijst (BPI-SF)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. evaluation during whole length of study
    2. evaluation during whole length of study

    3.1 imaging every 12 weeks, evaluation at 1 year
    3.2 questionnaire every 4 weeks, evaluation at 1 year
    4. questionnaire every 4 weeks, evaluation at 1 year
    1. gedurende hele lengte studie
    2. gedurende hele lengte studie

    3.1 beeldvorming elke 12 weken, evaluatie na 1 jaar
    3.2 vragenlijst elke 4 weken, evaluatie na 1 jaar
    4. vragenlijst elke 4 weken, evaluatie na 1 jaar
    E.5.2Secondary end point(s)
    1. Frequency of adverse events (AEs), as determined by Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03 criteria
    2. The proportion of subjects with disease recurrence after denosumab followed by surgery during the study
    3. Symptomatic improvement in the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire C30 (EORTC QLC-30) / BPI-SF, including:
    3.1) Change from baseline at 1 year, and
    3.2) Time to improvement in pain and time to worsening of pain
    4. Time to surgery (for subjects with salvageable disease), time to recurrence after surgery, progression free survival
    1. Frequentie van adverse events, volgens CTCAE v. 4.03 criteria
    2. Proportie van patiënten bij wie ziekte recidiveert na denosumab behandeling gevolgd door chirurgie
    3. Symptomatische verbetering op EORTC Kwaliteit van Leven C30 vragenlijst en Korte Pijn Vragenlijst (BPI-SF), inclusief:
    3.1) Verandering t.o.v. baseline na 1 jaar, en
    3.2) Tijd tot verbetering, en tijd tot verslechtering van pijnklachten
    4. Tijd tot chirurgie (voor patiënten met operabele ziekte), tijd tot recidief na chirurgie en progressie vrije overleving
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. AE registration every 4 weeks, evaluation after 1 jaar
    2. evaluation during whole length of study
    3.1 questionnaire every 4 weeks, evaluation at 1 year
    3.2 evaluation during whole length of study
    4. evaluation during whole length of study
    1. AE registratie elke 4 weken, evaluatie na 1 jaar
    2. gedurende hele lengte studie
    3.1 vragenlijst elke 4 weken, evaluatie na 1 jaar
    3.2 gedurende hele lengte studie
    4. gedurende hele lengte studie
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Translational research
    - Pathologic and molecular markers on tumor material
    - Evaluation / proportion of subjects with pathological response for subjects undergoing surgery
    Translationeel onderzoek
    - Pathologische en moleculaire markers op tumor materiaal
    - Evaluatie / proportie van pathologische respons na tumor resectie voor patiënten met operabele ziekte
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    The end of study is when all subjects enrolled have completed at least 60 months on study (treatment plus follow-up), or until death or loss to follow-up, whichever comes first.
    Einde van de studie is wanneer alle geincludeerde proefpersonen 60 maanden studiedeelname hebben volbracht (behandeling + followup), of tot aan overlijden of verlies in followup (afhankelijk van welke gebeurtenis zich als eerst voordoet).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Subjects will complete safety follow-up visits after denosumab is stopped every 6 months (± 1 month) for the 1st year and then every 12 months (± 1 month) thereafter until the end of study. Subjects will be asked about SAE’s, AEs of interest and disease treatments and outcomes.

    AEs of special interest include:
    • Osteonecrosis of the jaw
    • Malignancy, including malignancy in their giant cell rich tumor of bone
    • Atypical femoral fracture
    Proefpersonen worden na het staken van denosumab vervolgd voor follow-up van de veiligheidsdata. Gedurende het eerste jaar elke 6 maanden en daarna elke 12 maanden tot aan het einde van de studie. Proefpersonen wordt gevraagd naar SAE's, AE's met speciale interesse en verdere behandelingen en uitkomsten hiervan.

    AE's met speciale interesse:
    - Osteonecrose van de kaak
    - Maligniteiten, inclusief maligniteiten gerelateerd aan reusecelrijke tumor
    - Atypische femurfractuur
    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 Decision2018-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-04
    P. End of Trial
    P.End of Trial StatusOngoing
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