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Clinical trials for Denosumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    140 result(s) found for: Denosumab. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2018-000552-18 Sponsor Protocol Number: 1155/2018 Start Date*: 2019-12-06
    Sponsor Name:Medical University of Vienna
    Full Title: Denosumab in the prevention of immobilization-induced bone loss in Intensive Care Unit patients
    Medical condition: 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...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001041-17 Sponsor Protocol Number: 20060289 Start Date*: 2007-09-11
    Sponsor Name:Amgen Inc.
    Full Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis
    Medical condition: Treatment of postmenopausal osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed) SE (Completed) EE (Completed) DE (Completed) LV (Completed) GB (Completed) LT (Completed) HU (Completed) AT (Completed) FI (Completed) BE (Completed) MT (Completed) CZ (Completed) FR (Completed) ES (Completed) GR (Completed) IT (Completed) BG (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2017-005017-31 Sponsor Protocol Number: DERN Start Date*: 2019-01-29
    Sponsor Name:G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST
    Full Title: DENOSUMAB IN EBV RELATED NASOPHARYNGEAL CARCINOMA (NPC) AS A MODEL FOR RANK-MEDIATED IMMUNOLOGIC MODULATION OF VIRUS-RELATED TUMOURS – DERN STUDY
    Medical condition: advanced or metastatic Nose Pharynx Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028793 Nasopharyngeal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021846-23 Sponsor Protocol Number: 20080585 Start Date*: 2010-11-24
    Sponsor Name:Amgen Inc
    Full Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer
    Medical condition: Castrate-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10062904 Hormone-refractory prostate cancer LLT
    Population Age: Elderly Gender: Male
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-002096-17 Sponsor Protocol Number: EORTC-1762-STBSG Start Date*: 2020-04-21
    Sponsor Name:European Organisation for Research and Treatment of Cancer (EORTC)
    Full Title: Reduced dose-density of denosumab for maintenance therapy of unresectable giant cell tumor of bone: a multicenter phase II study "REDUCE"
    Medical condition: Giant cell tumor of bone
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10005968 Bone giant cell tumor LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) GB (GB - no longer in EU/EEA) DK (Completed) ES (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002678-11 Sponsor Protocol Number: ICO-13-001 Start Date*: 2018-06-07
    Sponsor Name:Institut Català d’Oncologia
    Full Title: An open label biomarker pilot study of the antitumoral acrivity of denosumab in the pre-operative setting of early breast cancer
    Medical condition: early breast cancer
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2010-020454-34 Sponsor Protocol Number: 20090482 Start Date*: 2012-05-09
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Disease in Subjects with Newly Diagnosed Multiple Myeloma
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Completed) DE (Completed) HU (Completed) CZ (Completed) GB (Completed) PT (Completed) IE (Completed) IT (Completed) AT (Completed) BG (Completed) SK (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001758-32 Sponsor Protocol Number: 20140114 Start Date*: 2017-08-29
    Sponsor Name:Amgen, Inc.
    Full Title: Long-term Safety Follow-up of Subjects With Giant Cell Tumour of Bone Treated With Denosumab in Study 20062004
    Medical condition: Giant Cell Tumour of Bone
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) ES (Ongoing) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-000339-93 Sponsor Protocol Number: 20050136 Start Date*: 2006-05-26
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer.
    Medical condition: Treatment of bone metastases in subjects with advanced breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10027452 Metastases to bone LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) NL (Completed) SK (Completed) GB (Completed) AT (Completed) ES (Completed) DE (Completed) LT (Completed) EE (Completed) BE (Completed) SE (Completed) LV (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-004903-15 Sponsor Protocol Number: 2020-004903-15 Start Date*: 2022-04-20
    Sponsor Name:University of Alabama at Birmingham
    Full Title: Denosumab (DMAB) Discontinuation and Switching Study in Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study
    Medical condition: Glucocorticoid-Induced Osteoporosis (GIOP)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-000341-19 Sponsor Protocol Number: 20050103 Start Date*: 2006-05-05
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer
    Medical condition: Metastatic castrate-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Completed) CZ (Completed) HU (Completed) ES (Completed) DE (Completed) NL (Completed) LT (Completed) SK (Completed) EE (Completed) SE (Completed) BE (Completed) LV (Completed) DK (Completed) IT (Completed) GR (Completed) FI (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2012-002887-29 Sponsor Protocol Number: Uni-Koeln-1574 Start Date*: 2013-02-13
    Sponsor Name:University of Cologne
    Full Title: Translational therapy in patients with Osteogenesis imperfecta - a pilot trial on treatment with the RANKL-antibody Denosumab
    Medical condition: In this study we will evaluate the efficacy of Denosumab in children with Osteogenesis imperfecta. Subjects will be treated every 12 weeks over 36 weeks with Denosumab 1mg/kg body weight s.c.. Effi...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003223-53 Sponsor Protocol Number: AGO/2015/008 Start Date*: 2015-12-01
    Sponsor Name:Ghent University Hospital
    Full Title: RANKL-blockade for the treatment of erosive osteoarthritis (OA) of interphalangeal finger joints Randomized, double blind, placebo-controlled study to evaluate the efficacy of denosumab 60mg sc ...
    Medical condition: erosive osteoarthritis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000848-65 Sponsor Protocol Number: 20050244 Start Date*: 2006-09-01
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate...
    Medical condition: Treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    8.1 10027452 Metastases to bone LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) PT (Completed) AT (Completed) NL (Completed) BE (Completed) HU (Completed) GB (Completed) LT (Completed) DE (Completed) SK (Completed) LV (Completed) SE (Completed) IT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2011-000541-20 Sponsor Protocol Number: STH15714 Start Date*: 2011-09-20
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: Effect of Denosumab on Osteolytic Lesion Activity in Total Hip Arthroplasty (THA)
    Medical condition: Prosthesis-related osteolysis after total hip arthroplasty
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10057128 Revision of hip arthroplasty LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-003156-21 Sponsor Protocol Number: ETOP_5-12/EORTC_08111 Start Date*: 2014-12-19
    Sponsor Name:ETOP (European Thoracic Oncology Platform)
    Full Title: A randomised, open-label phase III trial evaluating the addition of denosumab to standard first-line anticancer treatment in advanced NSCLC
    Medical condition: advanced NSCLC
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10025055 Lung cancer non-small cell stage IV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed) IE (Completed) DE (Completed) GB (Completed) AT (Completed) ES (Completed) SI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-001279-19 Sponsor Protocol Number: 20120187 Start Date*: 2014-03-26
    Sponsor Name:Amgen, Inc
    Full Title: A Multicenter, Double-blind, Randomized Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
    Medical condition: Post Menospausal Osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    16.1 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-000931-18 Sponsor Protocol Number: EL-THOS-001 Start Date*: 2014-05-27
    Sponsor Name:Ersi Voskaridou-Dimoula
    Full Title: EVALUATION OF EFFICACY OF DENOSUMAB IN PATIENTS WITH THALASSEMIA MAJOR AND OSTEOPOROSIS: A RANDOMIZED, PLACEBO-CONTROLLED, SINGLE-SITE, DOUBLE BLIND PHASE 2B CLINICAL TRIAL
    Medical condition: Adult patients with Thalassemia major and osteoporosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000693-57 Sponsor Protocol Number: Ledin03 Start Date*: 2011-11-29
    Sponsor Name:Håkan Ledin (investigator initiated trial)
    Full Title: A Randomized, Placebo-controlled, Double-blind, Two-center Study with Denosumab in Subjects Undergoing Elective Total Knee Replacement Surgery
    Medical condition: Patients with idiopathic osteoarthritis of the knee, scheduled for a cemented total knee prosthesis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000852-91 Sponsor Protocol Number: W15.032 Start Date*: 2016-06-02
    Sponsor Name:Leiden University Medical Center
    Full Title: Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation: AfterDmab
    Medical condition: Treatment of patients with with postmenopausal osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10050213 Prophylaxis against postmenopausal osteoporosis LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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