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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   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 5 of 7.
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    EudraCT Number: 2022-002312-23 Sponsor Protocol Number: LY06006/MRCT-301 Start Date*: 2023-05-25
    Sponsor Name:Shandong Boan Biotechnology Co., Ltd.
    Full Title: A randomized, double-blind, parallel-group, active-controlled comparative study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of LY06006 compared with EU-Prolia in postmeno...
    Medical condition: Postmenopausal osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BG (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005071-40 Sponsor Protocol Number: AVT03-GL-C01 Start Date*: 2022-10-31
    Sponsor Name:Alvotech Swiss AG
    Full Title: A Randomized, Double-Blind, Parallel Design, Repeat Dose, 2-arm, Multicenter Study Comparing the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profiles of AVT03 and US-Prolia® in Postmenopa...
    Medical condition: Osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031282 Osteoporosis PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002188-31 Sponsor Protocol Number: HLX14-002-PMOP301 Start Date*: 2022-11-25
    Sponsor Name:Shanghai Henlius Biotech, Inc.
    Full Title: A Randomized, Double-Blind, International Multicenter, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab I...
    Medical condition: Osteoporosis at High Risk of Fracture
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031282 Osteoporosis PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-006545-36 Sponsor Protocol Number: B1000-PMO-03-G-02 Start Date*: 2022-05-18
    Sponsor Name:Biocon Biologics UK Limited
    Full Title: A Randomized, Double-blind, Multicenter, Parallel-arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia in Postmenopausal Women with O...
    Medical condition: Postmenopausal women diagnosed with osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: EE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002187-49 Sponsor Protocol Number: EB-CLIN-1001-03 Start Date*: 2021-08-16
    Sponsor Name:Eden Biologics, Inc., Taiwan
    Full Title: A Multinational, Randomized, Double-Blind, Active-Controlled Phase 3 Study to Compare the Clinical Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EB1001 Biosimilar With EU-Licensed Pro...
    Medical condition: Osteoporosis is a disorder of impaired bone strength that results in skeletal fragility and increased fracture risk. It is a common and costly disorder, and is associated with significant morbidity...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Prematurely Ended) EE (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005991-28 Sponsor Protocol Number: 20060326 Start Date*: 2009-06-26
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 785 in the Treatment of Postmenopausal Women with Low Bone Mineral Density
    Medical condition: Postmenopausal 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: AT (Completed) ES (Completed) DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001461-32 Sponsor Protocol Number: OGX-011-12 Start Date*: 2012-07-12
    Sponsor Name:OncoGenex Technologies Inc.
    Full Title: A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy in Men with Metastatic Castrate Resistant ...
    Medical condition: Metastatic Castrate Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    18.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-002505-62 Sponsor Protocol Number: STH16404 Start Date*: 2013-11-14
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: SarCaBon: A randomised phase II trial of Saracatinib versus placebo for cancer-induced bone pain
    Medical condition: Cancer-induced bone pain
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10049038 Metastatic bone pain LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-003132-24 Sponsor Protocol Number: RXC004/0002 Start Date*: 2021-07-26
    Sponsor Name:Redx Pharma Plc
    Full Title: A Multi-arm, Phase II, Open-Label, Multicentre Study to Assess the Preliminary Efficacy of RXC004 in Monotherapy and in Combination with Nivolumab, in Patients with Ring Finger Protein 43 (RNF43) o...
    Medical condition: Patients with Ring Finger Protein 43 (RNF43) or R-spondin (RSPO) Aberrated, Metastatic, Microsatellite Stable, Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-002814-38 Sponsor Protocol Number: SP005 Start Date*: 2013-09-27
    Sponsor Name:SOTIO a.s.
    Full Title: A Randomized, Double Blind, Multicenter, Parallel-group, Phase III study to evaluate efficacy and safety of DCVAC/PCa versus Placebo in Men with metastatic Castration Resistant Prostate Cancer elig...
    Medical condition: metastatic castrate-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) GB (Completed) DE (Completed) BE (Completed) CZ (Completed) IT (Completed) NL (Completed) ES (Completed) HU (Completed) PT (Completed) BG (Completed) SK (Completed) PL (Completed) HR (Completed) AT (Completed) LV (Completed) LT (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-001965-42 Sponsor Protocol Number: MYL-Her3001 Start Date*: 2013-03-01
    Sponsor Name:MYLAN GmbH
    Full Title: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE III STUDY OF THE EFFICACY AND SAFETY OF HERCULES PLUS TAXANE VERSUS HERCEPTIN® PLUS TAXANE AS FIRST LINE THERAPY IN PATIENTS WITH HER2...
    Medical condition: Human Epidermal Growth Factor Receptor 2 positive (HER2+) metastatic breast cancer (MBC)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Completed) BG (Completed) CZ (Completed) SK (Completed) LV (Completed) ES (Prematurely Ended) GR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-006085-40 Sponsor Protocol Number: 2011-006085-40 Start Date*: 2012-12-17
    Sponsor Name:Cliniques Universitaires Saint Luc
    Full Title: A proof of concept study to evaluate the use of metabonomics and lipidomics in predicting toxicity and efficacy of anti-VEGF therapy in patients with metastatic clear cell renal cell carcinoma.
    Medical condition: Metastatic clear cell renal cell carcinoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002669-13 Sponsor Protocol Number: 87RI21_0052 Start Date*: 2022-11-25
    Sponsor Name:Limoges University Hospital
    Full Title: The PENTO protocol in Medication-related osteonecrosis of the jaw (MRONJ): a single-center phase IIa trial
    Medical condition: Medication-related osteonecrosis of the jaw (MRONJ)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004859 10084881 Medication-related osteonecrosis of jaw LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003203-14 Sponsor Protocol Number: TUXEDO-2 Start Date*: 2023-05-02
    Sponsor Name:Med. Univ. Wien, Klinik f. Innere Medizin I, Onkologie
    Full Title: Phase II Study of daTopotamab-derUXtecan (Dato-DXd; DS-1026a) in triple-negative brEast cancer patients with newly Diagnosed or prOgressing brain metastases
    Medical condition: triple negative breast cancer with newly diagnosed or progressing brain metastases
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2004-000512-17 Sponsor Protocol Number: 20040138 Start Date*: 2004-10-01
    Sponsor Name:Amgen Inc
    Full Title: A Randomized, Double-Blind, Placebo-controlled Study to Evaluate AMG 162 in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-metastatic Prostate Cancer
    Medical condition: Bone loss in pateints undergoing androgen-deprivation therapy (ADT) for non-metastatic prostate cancer.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10049470 Bone density decreased LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: FI (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2018-003724-36 Sponsor Protocol Number: CODIF-008 Start Date*: 2020-04-24
    Sponsor Name:Ole Lander Svendsen
    Full Title: The DENOCHARCOT trial Efficacy of treatment with DENOsumab of an acute CHARCOT foot in patients with diabetes. A multicenter, double-blind, randomized, placebo-controlled trial.
    Medical condition: acute Charcot foot (Charcot arthropathy; ICD-10: DM14.6) in patients with diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10008408 Charcot arthropathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-021011-16 Sponsor Protocol Number: OGX-011-11 Start Date*: 2010-09-27
    Sponsor Name:Teva Pharmaceutical Industries, Ltd
    Full Title: A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer
    Medical condition: metastatic castrate resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10062904 Hormone-refractory prostate cancer LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: HU (Completed) FR (Completed) DE (Completed) ES (Completed) BE (Completed) NL (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004322-24 Sponsor Protocol Number: ARN-509-003 Start Date*: 2013-08-27
    Sponsor Name:Aragon Pharmaceuticals, Inc
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
    Medical condition: Castration-Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: AT (Trial now transitioned) FI (Completed) SE (Completed) NL (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) NO (Completed) DE (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned) HU (Completed) CZ (Trial now transitioned) SK (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-005665-12 Sponsor Protocol Number: MDV3100-14(C3431005) Start Date*: 2013-09-06
    Sponsor Name:Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.
    Full Title: A Multinational, Phase 3, Randomized, Double Blind, Placebo Controlled, Efficacy and Safety Study of Enzalutamide in Patients With Nonmetastatic Castration Resistant Prostate Cancer
    Medical condition: Patients With Nonmetastatic Castration Resistant Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10060862 Prostate cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: SE (Completed) IT (Completed) AT (Completed) BE (Completed) GB (GB - no longer in EU/EEA) SK (Completed) FI (Completed) NL (Completed) ES (Completed) GR (Completed) FR (Completed) DK (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002113-39 Sponsor Protocol Number: BAY88-8223/16298 Start Date*: 2014-10-29
    Sponsor Name:Bayer AG
    Full Title: A phase II randomized, double-blind, placebo-controlled trial of radium-223 dichloride versus placebo when administered to metastatic HER2 negative hormone receptor positive breast cancer subjects ...
    Medical condition: HER2 negative hormone receptor positive metastatic breast cancer with bone metastases treated with standard of care hormonal treatment.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10055113 Breast cancer metastatic PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: GB (Completed) ES (Completed) AT (Completed) NO (Completed) CZ (Completed) DK (Prematurely Ended) NL (Completed) SE (Completed) PL (Completed) FI (Completed) IE (Completed) FR (Completed) DE (Completed)
    Trial results: View results
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