Clinical trial • Not applicable • Musculoskeletal|Dermatology|Rare Disease|Other
Romosozumab for Osteogenesis imperfecta
Not applicable trial of Romosozumab for Osteogenesis imperfecta. open-label. 39 participants.
Overview
- Trial Therapeutic Area
- Musculoskeletal|Dermatology|Rare Disease|Other
- Trial Disease
- Osteogenesis imperfecta
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-10-2025
- First CTIS Authorization Date
- 23-02-2026
Trial design
open-label Not applicable trial across 14 sites in Austria, Belgium, Germany and others.
- Open Label
- Yes
- Target Sample Size
- 39
- Trial Duration For Participant
- 749
Eligibility
Recruits 39 paediatric patients.
- Vulnerable Population
- Includes children and adolescents. If participant is legally too young to provide informed consent, the participant’s legally authorized representative must provide informed consent; the participant must provide written assent based on local regulations and/or guidelines prior to initiation of study-specific activities/procedures. Age-specific assent/ICF documents are provided (child age groups 5-7 and 8-11, adolescent, parental, adult) and country-specific informed consent/assent materials are included in the documentation.
Inclusion criteria
- {"criterion_text":"-101 Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures."}
- {"criterion_text":"-101 Participant’s legally authorized representative has provided informed consent when the participant is legally too young to provide informed consent, and the participant has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated."}
- {"criterion_text":"-102 Participant was randomized to the romosozumab arm and completed Study 20200105 through the Month 15 Visit, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early."}
Exclusion criteria
- {"criterion_text":"-201 Currently receiving treatment in another investigational device or drug study, or less than 2 years since ending treatment on another investigational device or drug study(ies) with the exception of Study 20200105. Other investigational procedures while participating in this study are excluded."}
- {"criterion_text":"-202 Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator’s knowledge."}
Endpoints
Primary endpoints
- {"endpoint_text":"-Adverse events","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 39
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent must be provided prior to any study-specific activities. If the participant is legally too young to provide consent, a legally authorized representative provides informed consent and the participant provides written assent per local regulations/guidelines. Age-specific ICF/assent documents are provided (documents for adults, parental ICF, adolescent ICF/assent, child assent for ages 5-7 and 8-11, and other child/adolescent materials). Consent/assent materials are available in multiple languages as provided in the documentation (including English, French, Dutch, German, Italian, Spanish, Hungarian, Slovak).
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 32
Austria
- Earliest CTIS Part Ii Submission Date
- 14-01-2026
- Latest Decision Or Authorization Date
- 23-02-2026
- Processing Time Days
- 40
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Pediatrics and Adolescent Medicine
- Principal Investigator Name
- Wolfgang Högler
- Principal Investigator Email
- Wolfgang.Hoegler@kepleruniklinikum.at
- Contact Person Name
- Wolfgang Högler
- Contact Person Email
- Wolfgang.Hoegler@kepleruniklinikum.at
- Number Of Participants
- 3
Belgium
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 27-02-2026
- Processing Time Days
- 32
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- UZ Leuven
- Department Name
- Pediatrics
- Principal Investigator Name
- Peter Witters
- Principal Investigator Email
- peter.witters@uzleuven.be
- Contact Person Name
- Peter Witters
- Contact Person Email
- peter.witters@uzleuven.be
- Number Of Participants
- 2
Germany
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 25-02-2026
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Muskuloskelettales Zentrum
- Principal Investigator Name
- Lothar Seefried
- Principal Investigator Email
- lothar.seefried@klh.de
- Contact Person Name
- Lothar Seefried
- Contact Person Email
- lothar.seefried@klh.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- Klinik und Poliklinik fuer Kinder- und Jugendmedizin
- Principal Investigator Name
- Heike-Katharina Hoyer-Kuhn
- Principal Investigator Email
- heike-katharina.hoyer-kuhn@uk-koeln.de
- Contact Person Name
- Heike-Katharina Hoyer-Kuhn
- Contact Person Email
- heike-katharina.hoyer-kuhn@uk-koeln.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 10-12-2025
- Latest Decision Or Authorization Date
- 26-02-2026
- Processing Time Days
- 78
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Semmelweis University
- Department Name
- Gyermekgyogyaszati Klinika Tuzolto utcai reszleg
- Principal Investigator Name
- Eva Hosszu
- Principal Investigator Email
- hosszu.eva@semmelweis.hu
- Contact Person Name
- Eva Hosszu
- Contact Person Email
- hosszu.eva@semmelweis.hu
- Number Of Participants
- 5
Italy
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 41
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Ospedale Pediatrico Bambino Gesu
- Department Name
- University Hospital Pediatric Department
- Principal Investigator Name
- Michaela Veronika Gonfiantini
- Principal Investigator Email
- mveronik.gonfiantini@opbg.net
- Contact Person Name
- Michaela Veronika Gonfiantini
- Contact Person Email
- mveronik.gonfiantini@opbg.net
- Site Name
- Centro Ricerche Cliniche Di Verona S.r.l.
- Department Name
- Clinical Pharmacology Unit
- Principal Investigator Name
- Franco Antoniazzi
- Principal Investigator Email
- franco.antoniazzi@univr.it
- Contact Person Name
- Franco Antoniazzi
- Contact Person Email
- franco.antoniazzi@univr.it
- Site Name
- IRCCS Istituto Giannina Gaslini
- Department Name
- Complex Operating Unit for Pediatrics and Endocrinology
- Principal Investigator Name
- Natascia Di Iorgi
- Principal Investigator Email
- natasciadiiorgi@gaslini.org
- Contact Person Name
- Natascia Di Iorgi
- Contact Person Email
- natasciadiiorgi@gaslini.org
Spain
- Earliest CTIS Part Ii Submission Date
- 04-02-2026
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Universitario De Getafe
- Department Name
- Pediatrics
- Principal Investigator Name
- Nuria Lopez Barrena
- Principal Investigator Email
- nlbarrena@hotmail.com
- Contact Person Name
- Nuria Lopez Barrena
- Contact Person Email
- nlbarrena@hotmail.com
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Pediatric Endocrinology
- Principal Investigator Name
- Gema Grau Bolado
- Principal Investigator Email
- MARIAGEMA.GRAUBOLADO@osakidetza.eus
- Contact Person Name
- Gema Grau Bolado
- Contact Person Email
- MARIAGEMA.GRAUBOLADO@osakidetza.eus
- Site Name
- Hospital Sant Joan De Deu Barcelona
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Rosa Bou Torrent
- Principal Investigator Email
- rosa.bou@sjd.es
- Contact Person Name
- Rosa Bou Torrent
- Contact Person Email
- rosa.bou@sjd.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Ariadna Campos Martorell
- Principal Investigator Email
- ariadna.campos@vallhebron.cat
- Contact Person Name
- Ariadna Campos Martorell
- Contact Person Email
- ariadna.campos@vallhebron.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Lucia Lacruz Perez
- Principal Investigator Email
- lacruz_lucper@gva.es
- Contact Person Name
- Lucia Lacruz Perez
- Contact Person Email
- lacruz_lucper@gva.es
Slovakia
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 24-02-2026
- Processing Time Days
- 5
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Narodny Ustav Detskych Chorob
- Department Name
- Detska klinika LF UK a NUDCH
- Principal Investigator Name
- Lubica Ticha
- Principal Investigator Email
- lubica.ticha@nudch.eu
- Contact Person Name
- Lubica Ticha
- Contact Person Email
- lubica.ticha@nudch.eu
- Number Of Participants
- 2
Sponsor
Primary sponsor
- Full Name
- Amgen Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Bioclinica Inc.
- Responsibilities
- Imaging
- Name
- Q Squared Solutions Limited
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- EVENITY 105 mg solution for injection in pre-filled syringe
- Active Substance
- Romosozumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Starting Dose
- 105 mg
- Dose Levels
- 105 mg
- Investigational Product Name
- EVENITY 105 mg solution for injection in pre-filled syringe
- Active Substance
- Romosozumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Starting Dose
- 105 mg
- Dose Levels
- 105 mg
- Investigational Product Name
- EVENITY 105 mg solution for injection in pre-filled pen
- Active Substance
- Romosozumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Starting Dose
- 105 mg
- Dose Levels
- 105 mg
- Investigational Product Name
- EVENITY 105 mg solution for injection in pre-filled pen
- Active Substance
- Romosozumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised
- Starting Dose
- 105 mg
- Dose Levels
- 105 mg
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