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Clinical trials for Osteogenesis Imperfecta

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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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    18 result(s) found for: Osteogenesis Imperfecta. Displaying page 1 of 1.
    EudraCT Number: 2016-003606-14 Sponsor Protocol Number: SCH-2013 Start Date*: 2017-01-31
    Sponsor Name:Sheffield Children's NHS Foundation Trust
    Full Title: Do bisphosphonates alter the skeletal response to mechanical stimulation in children with osteogenesis imperfecta?
    Medical condition: Osteogenesis Imperfecta
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-001465-41 Sponsor Protocol Number: CBPS804A2201 Start Date*: 2011-07-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of B...
    Medical condition: Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comp...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (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 (Ongoing) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000745-21 Sponsor Protocol Number: P1200_12 Start Date*: 2012-12-10
    Sponsor Name:Schriners Hospitals for Children
    Full Title: An international, multicenter, open-label, efficacy and safety trial of intravenous zoledronic acid in infants less than one year of age, with severe osteogenesis imperfecta
    Medical condition: Children suffering from severe Osteogenesis Imperfecta
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002622-39 Sponsor Protocol Number: PEDFOI Start Date*: 2015-11-18
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    Full Title: Experimental Study Protocol on Treatment with plasma transfusions in Patients affected by type VI Osteogenesis Imperfecta
    Medical condition: type VI Osteogenesis Imperfecta
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10031243 Osteogenesis imperfecta PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (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: 2018-000550-21 Sponsor Protocol Number: 20170534 Start Date*: 2018-07-06
    Sponsor Name:Amgen Inc
    Full Title: Multicenter, Single-arm Open-label Extension Study to Assess Long term Safety and Efficacy of Current or Prior Treatment with Denosumab in Children/Young Adults with Osteogenesis Imperfecta
    Medical condition: Osteogenesis Imperfecta (OI)
    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, Adults Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) PL (Prematurely Ended) BE (Ongoing) DE (Completed) GB (GB - no longer in EU/EEA) ES (Prematurely Ended) CZ (Completed) FR (Completed) BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003539-37 Sponsor Protocol Number: CZOL446H2202 Start Date*: 2016-03-07
    Sponsor Name:Novartis
    Full Title: An international, multicenter, randomized, open-label, parallel efficacy, and safety trial of intravenous zoledronic acid compared to intravenous pamidronate in children with severe osteogenesis im...
    Medical condition: Osteogenesis Imperfecta
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006597-23 Sponsor Protocol Number: UX143-CL301 Start Date*: Information not available in EudraCT
    Sponsor Name:Ultragenyx Pharmaceutical Inc.
    Full Title: A Randomized, Double-Blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta.
    Medical condition: Osteogenesis imperfecta (OI)
    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, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing) DK (Prematurely Ended) DE (Ongoing) IT (Ongoing) PL (Ongoing) PT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003228-22 Sponsor Protocol Number: AC16092 Start Date*: 2016-12-14
    Sponsor Name:University of Edinburgh [...]
    1. University of Edinburgh
    2. NHS Lothian
    Full Title: Treatment of Osteogenesis Imperfecta with Parathyroid hormone and Zoledronic acid
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Ongoing) DK (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000485-13 Sponsor Protocol Number: 2003100 - HMR4003I/3001 Start Date*: 2006-03-28
    Sponsor Name:Procter & Gamble Ltd
    Full Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study of One-year Duration Followed by 2 Years of Open-label Treatment to Determine the Safety and Efficacy of Orally Adm...
    Medical condition: Osteogenesis Imperfecta
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) BE (Completed) ES (Completed) HU (Completed) CZ (Completed) DK (Completed)
    Trial results: (No results available)
    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: 2016-005096-27 Sponsor Protocol Number: MBPS205 Start Date*: 2017-06-23
    Sponsor Name:Mereo BioPharma 3 Ltd.
    Full Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusu...
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) GB (GB - no longer in EU/EEA) FR (Completed)
    Trial results: View results
    EudraCT Number: 2004-005275-42 Sponsor Protocol Number: 1140 Start Date*: 2005-03-21
    Sponsor Name:AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
    Full Title: Study on the effect of r-hGH in combination with bisphosphonate treatment on bone metabolism in Osteogenesis Imperfecta
    Medical condition: Osteogenesis Imperfecta
    Disease: Version SOC Term Classification Code Term Level
    6.1 10010331 SOC
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-002811-27 Sponsor Protocol Number: OI-2011 Start Date*: 2011-11-07
    Sponsor Name:Bente Langdahl, consultant, ass. professor, PhD, DMSc
    Full Title: The Effect of Treatment with PTH and Zoledronic acid in Patients with Osteogenesis Imperfecta
    Medical condition: Osteogenesis imperfecta
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-001666-40 Sponsor Protocol Number: CZOL446H2202E1 Start Date*: 2005-02-01
    Sponsor Name:Novartis Pharma AG
    Full Title: An international, multicenter, randomized, open-label, safety and efficacy trial of intravenous zoledronic acid administered either once or twice yearly in children with severe osteogenesis imperfe...
    Medical condition: Osteogenesis Imperfecta
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-002553-38 Sponsor Protocol Number: TERCELOI Start Date*: 2013-08-09
    Sponsor Name:Itziar Astigarraga Aguirre
    Full Title: Mesenchymal stem cell based therapy for the treatment of osteogenesis imperfecta
    Medical condition: Osteogenesis imperfecta (OI) is a rare genetic disorder with increased bone fragility of varying severity. In the majority of patients the disease is caused by mutations in collagen type I. Severe ...
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003699-60 Sponsor Protocol Number: KIBB01 Start Date*: 2018-09-28
    Sponsor Name:Karolinska Institutet
    Full Title: An exploratory, open label, multiple dose, multicentre phase I/II trial evaluating safety and efficacy of postnatal or prenatal and postnatal intravenous administration of allogeneic expanded fetal...
    Medical condition: Treatment of Osteogenesis Imperfecta (OI) type III and severe type IV.
    Disease:
    Population Age: In utero, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Temporarily Halted)
    Trial results: (No results available)
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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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