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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
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    • 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   44341   clinical trials with a EudraCT protocol, of which   7370   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 2 of 7.
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    EudraCT Number: 2011-006224-21 Sponsor Protocol Number: IJB-BCTL-20119167 Start Date*: 2013-06-20
    Sponsor Name:Jules Bordet Institute
    Full Title: A pre-operative window study evaluating Denosumab, a RANK-Ligand (RANKL) inhibitor and its biological effects in young pre-menopausal women diagnosed with early breast cancer
    Medical condition: We have designed this study to investigate if denosumab can modulate a number of biological processes including prolferation, RANK signaling and the mammary stem cell subpopulation.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10006190 Breast cancer invasive NOS LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-005485-37 Sponsor Protocol Number: 20050147 Start Date*: 2006-06-05
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on 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 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Completed) GB (Completed) CZ (Completed) BE (Completed) IE (Completed) SK (Completed) HU (Completed) ES (Completed) PT (Completed) DE (Completed) IT (Completed) LT (Completed) LV (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-000655-24 Sponsor Protocol Number: CBG-study2 Start Date*: 2015-04-28
    Sponsor Name:rigshospitalet
    Full Title: Denosumab and male infertility: a prospective intervention study
    Medical condition: Male infertility especially low sperm count
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038604 - Reproductive system and breast disorders 10021929 Infertility male PT
    Population Age: Adults Gender: Male
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-002366-41 Sponsor Protocol Number: AIEOP-ISGOsM+ Start Date*: 2021-09-28
    Sponsor Name:ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
    Full Title: Phase II, multicenter, randomized, open-label study with MAP +/- denosumab regimen for the treatment of patients with metastatic osteosarcoma
    Medical condition: Metastatic osteosarcoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10031294 Osteosarcoma metastatic PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-009756-21 Sponsor Protocol Number: 20070315 Start Date*: 2009-10-26
    Sponsor Name:Amgen Inc
    Full Title: A Single-arm, Multicenter, Proof-of-concept Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects with Elevated Serum Calcium Despite Recent Treatment with IV Bisphosphonates.
    Medical condition: Hypercalcemia of malignancy (HCM)
    Disease: Version SOC Term Classification Code Term Level
    15.0 10014698 - Endocrine disorders 10020588 Hypercalcemia of malignancy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011299-32 Sponsor Protocol Number: 20060359 Start Date*: 2010-08-06
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence
    Medical condition: Early-stage non-metastatic breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10006190 Breast cancer invasive NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: PT (Completed) HU (Completed) GB (Completed) ES (Prematurely Ended) CZ (Completed) LV (Completed) FR (Completed) BE (Completed) SK (Completed) NL (Completed) IE (Prematurely Ended) DK (Completed) SI (Completed) GR (Completed) IT (Completed) BG (Completed) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005275-15 Sponsor Protocol Number: 20050209 Start Date*: 2006-07-11
    Sponsor Name:Amgen Limited
    Full Title: A Randomized, Double- Blind, Placebo- Controlled, Multi- Center Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects with Non- Metastatic Breast Cancer Receiving Aromatase Inhib...
    Medical condition: Early non-metastatic breast cancer and therapy-induced bone loss and fractures
    Disease: Version SOC Term Classification Code Term Level
    21.1 10028395 - Musculoskeletal and connective tissue disorders 10065687 Bone loss PT
    21.1 100000004864 10006188 Breast cancer female NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001662-42 Sponsor Protocol Number: 20120249 Start Date*: 2014-02-11
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-blind, Multi-center Phase 2 Trial of Denosumab in Combination With Chemotherapy as First-line Treatment of Metastatic Non-small Cell Lung Cancer
    Medical condition: Non-small Cell Lung Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) IT (Completed) GB (Completed) GR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-005081-37 Sponsor Protocol Number: 20050141 Start Date*: 2006-06-12
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind Study to Compare the Efficacy of Treatment with Denosumab versus Alendronate Sodium in Postmenopausal Women with Low Bone Mineral Density
    Medical condition: Postmenopausal osteoporosis /osteopenia
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) BE (Completed) ES (Completed) DE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-003570-11 Sponsor Protocol Number: BC-6072 Start Date*: 2019-10-21
    Sponsor Name:Ghent University Hospital
    Full Title: The use of buffered soluble alendronate 70 mg (Steovess/Binosto) after denosumab discontinuation to prevent increase in bone turnover.
    Medical condition: erosive osteoarthritis of the interphalangeal finger joints
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10016686 Finger osteoarthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000924-32 Sponsor Protocol Number: AGMT_MM-3 Start Date*: 2018-12-07
    Sponsor Name:AGMT gGmbH
    Full Title: Denosumab for high risk SMM and SLiM CRAB positive, early myeloma patients- a randomized, placebo controlled phase II trial “DEFENCE” (DEnosumab For the rEductioN of the smoldering myeloma transfor...
    Medical condition: High-risk smouldering multiple myeloma or "SLiM CRAB" positive early multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10067386 Multiple myeloma transformation LLT
    20.0 100000004864 10075894 Smoldering myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005271-15 Sponsor Protocol Number: 20050179 Start Date*: 2007-07-18
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment with Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women with Low Bone Mineral De...
    Medical condition: Postmenopausal osteoporosis /osteopenia
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006964-48 Sponsor Protocol Number: 20040215 Start Date*: 2007-04-13
    Sponsor Name:Amgen Inc
    Full Title: An Open-Label, Multi-Center, Phase 2 Safety and Efficacy Study of Denosumab (AMG 162) in Subjects with Recurrent or Unresectable Giant Cell Tumor (GCT) of Bone
    Medical condition: Giant Cell Tumor (GCT) of bone
    Disease: Version SOC Term Classification Code Term Level
    9.1 10005968 Bone giant cell tumor LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003300-31 Sponsor Protocol Number: 20159460(c) Start Date*: 2017-06-13
    Sponsor Name:Hellenic Society for the Study of Bone Metabolism
    Full Title: Evaluation of the efficacy of Denosumab in adult patients with Langerhans Cell Histiocytosis (LCH) : a multiple-site, single arm, open label Clinical Trial.
    Medical condition: Langerhans Cell Histiocytosis (LCH) is a rare disease of unknown etiology with variable clinical course exhibiting both neoplastic and inflammatory features. It is characterized by the accumulatio...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10069698 Langerhans' cell histiocytosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000184-40 Sponsor Protocol Number: 20130173 Start Date*: 2014-09-11
    Sponsor Name:Amgen, Inc.
    Full Title: Prospective, Multicenter, Single-arm Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Denosumab in Children With Osteogenesis Imperfecta
    Medical condition: Osteogenesis Imperfecta
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) GB (GB - no longer in EU/EEA) HU (Completed) ES (Completed) Outside EU/EEA BG (Completed) PL (Prematurely Ended) BE (Completed) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-009374-27 Sponsor Protocol Number: 20080540 Start Date*: 2009-08-27
    Sponsor Name:Amgen Inc
    Full Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma
    Medical condition: Bone metastases in subjects with advanced cancer or multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005993 Bone metastases LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-002114-36 Sponsor Protocol Number: 20110113 Start Date*: 2011-10-04
    Sponsor Name:Amgen Inc
    Full Title: Open-Label Access Protocol of Denosumab for Subjects with Advanced Cancer
    Medical condition: Bone Metastases in Subjects with Advanced Breast Cancer and Bone Metastases in Men with Hormone-Refractory Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    16.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027475 Metastatic breast cancer LLT
    16.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005993 Bone metastases LLT
    16.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) AT (Completed) FR (Completed) ES (Completed) PL (Completed) BE (Completed) LV (Completed) LT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-005343-23 Sponsor Protocol Number: ADAIDO Start Date*: 2021-05-28
    Sponsor Name:IRCCS ISTITUTO ORTOPEDICO GALEAZZI S.P.A
    Full Title: Effect of the antiresorptive treatment with alendronate versus no treatment after denosumab and aromatase inhibitors discontinuation in low fracture risk osteopenic postmenopausal women with non me...
    Medical condition: post-menopausal osteoporosis in women with non-metastatic hormonal receptor positive (HR+) breast cancer.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10049088 Osteopenia PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-001606-16 Sponsor Protocol Number: 20062004 Start Date*: 2009-01-16
    Sponsor Name:Amgen Inc
    Full Title: An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects with Giant Cell Tumor of Bone
    Medical condition: Giant cell tumor of bone (GCTB)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10005968 Bone giant cell tumor LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) AT (Completed) FR (Completed) ES (Completed) GB (Completed) PL (Completed) IT (Completed) SE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-006154-17 Sponsor Protocol Number: 20080537 Start Date*: 2009-07-20
    Sponsor Name:Amgen Inc
    Full Title: An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastati...
    Medical condition: medical condition should be "Bone Loss in patients undergoing androgen-deprivation therapy (ADT) for non-metastatic prostate cancer"
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065687 Bone loss LLT
    9.1 10060862 Prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Completed) CZ (Completed) HU (Completed) PL (Completed) FI (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
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