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Clinical trials for Romosozumab

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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    10 result(s) found for: Romosozumab. Displaying page 1 of 1.
    EudraCT Number: 2017-003512-40 Sponsor Protocol Number: 20150120 Start Date*: 2018-03-05
    Sponsor Name:Amgen Inc.
    Full Title: A Randomized, Multicenter, Open-label, Parallel Group Study in Postmenopausal Women With Osteoporosis to Evaluate the Noninferiority of Subject-administered Romosozumab via Autoinjector/Pen vs Heal...
    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: GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-004972-74 Sponsor Protocol Number: 20160227 Start Date*: 2020-09-15
    Sponsor Name:Amgen Inc.
    Full Title: An Open-label, Ascending Multiple dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
    Medical condition: Osteogenesis imperfecta (OI) is a group of genetic skeletal disorders characterized by increased bone fragility, low bone mass , and increased bone turnover contributing to osteoporosis, fracture...
    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: HU (Completed) DE (Completed) GR (Completed) IT (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000434-35 Sponsor Protocol Number: 20120156 Start Date*: 2013-12-10
    Sponsor Name:Amgen, Inc
    Full Title: A Multicenter, Randomized, Multiple-dose Phase 3 Study to Evaluate the Noninferiority of Romosozumab at a 90 mg/mL Concentration Compared With a 70 mg/mL Concentration in Postmenopausal Women With...
    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: PL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-003142-41 Sponsor Protocol Number: 20110142 Start Date*: 2012-03-28
    Sponsor Name:AMGEN INC.
    Full Title: A Multicenter, International, Randomized, Double-blind, Alendronate-controlled Study to Determine the Efficacy and Safety of AMG 785 in the Treatment of Postmenopausal Women With Osteoporosis
    Medical condition: Postmenopausal osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) LT (Completed) FI (Completed) PL (Completed) BE (Completed) CZ (Completed) ES (Completed) EE (Completed) GR (Completed) DE (Completed) GB (Completed) SE (Completed) AT (Completed) DK (Completed) LV (Completed) NO (Completed) NL (Completed) HU (Completed) IE (Completed) SK (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-000675-90 Sponsor Protocol Number: 20160397 Start Date*: 2017-05-30
    Sponsor Name:Amgen Inc.
    Full Title: A Phase 3b, Multicenter, Randomized, Double-blind, Parallel Group, Alendronate-Controlled Study in Postmenopausal Women with Osteoporosis Previously Treated with Romosozumab Followed by Alendronate...
    Medical condition: Postmenopausal osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: CZ (Prematurely Ended) LT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-005551-32 Sponsor Protocol Number: 20110174 Start Date*: 2014-06-16
    Sponsor Name:Amgen, Inc.
    Full Title: A Multicenter, Randomized, Double blind, Placebo controlled Study to Compare the Efficacy and Safety of Romosozumab With Placebo in Men With Osteoporosis
    Medical condition: male osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10028395 - Musculoskeletal and connective tissue disorders 10031282 Osteoporosis PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: CZ (Completed) BE (Completed) DK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001456-11 Sponsor Protocol Number: 20070337 Start Date*: 2012-04-17
    Sponsor Name:Amgen Inc
    Full Title: A Multicenter, International, Randomized, Double-blind, Placebo controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
    Medical condition: Postmenopausal Osteoporosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Completed) BE (Completed) DK (Completed) PL (Completed) DE (Completed) GB (Completed) EE (Completed) CZ (Completed) ES (Completed) LV (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002948-24 Sponsor Protocol Number: 20080289 Start Date*: 2013-04-08
    Sponsor Name:Amgen, Inc.
    Full Title: An Open-label, Randomized, Teriparatide-controlled Study to Evaluate the Effect of Treatment with AMG 785 in Postmenopausal Women with Osteoporosis Previously Treated with Bisphosphonate Therapy
    Medical condition: Post Menopausal 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: BE (Completed) DK (Completed) ES (Completed) GB (Completed) CZ (Completed) HU (Completed)
    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: 2020-001479-34 Sponsor Protocol Number: SB16-3001 Start Date*: 2020-11-10
    Sponsor Name:Samsung Bioepis Co., Ltd.
    Full Title: A Phase III, Randomised, Double-blind, Multicentre Clinical Study to Compare the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity between SB16 (proposed denosumab biosimilar...
    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: LT (Completed) DK (Completed) CZ (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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