A safety study of romosozumab in children and adolescents with osteogenesis imperfecta

3 1 1 1

What is this study about?

This study focuses on children and adolescents living with Osteogenesis Imperfecta, a rare genetic condition that causes bones to be fragile and more likely to break. The purpose of the study is to evaluate the safety of a medication called romosozumab in individuals who have previously used this treatment.

Participants in this research have already completed a prior study involving the administration of romosozumab via subcutaneous injection, which is a method of delivering medication through a needle into the fatty layer of the skin just under the surface. The study involves monitoring these individuals over time to observe any adverse events, which are unexpected or undesirable medical occurrences that may happen after using a drug.

Who Can Join the Study?

  • You must have osteogenesis imperfecta, which is a condition that causes bones to be fragile and break easily.
  • You or your legally authorized representative (a person allowed by law to make medical decisions for you, such as a parent or guardian) must sign a consent form, which is a document that explains the study and shows you agree to participate.
  • If you are too young to sign a legal consent form, you must provide assent, which means you personally agree to take part in the study.
  • You must have been part of a previous study called Study 20200105 and received the medication romosozumab.
  • You must have finished the 15-month visit of that previous study, even if you stopped taking the medication earlier than planned.

Who Cannot Join the Study?

  • You cannot participate if you are currently taking part in another study involving an investigational drug (a medicine being tested for the first time) or an investigational device (a medical tool being tested for the first time).
  • You cannot participate if it has been less than 2 years since you finished a different study involving an investigational drug or investigational device, unless that study was Study 20200105.
  • You cannot participate if you are undergoing other investigational procedures (medical tests or treatments that are still being researched) while participating in this study.
  • You cannot participate if it is unlikely that you will be able to attend all the required study visits (scheduled appointments to check your progress) or follow all the rules and steps required by the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
IRCCS Istituto Giannina Gaslini Genoa Italy
Hospital Sant Joan De Deu Barcelona Esplugues De Llobregat Spain
Hospital Universitario De Getafe Getafe Spain
Narodny Ustav Detskych Chorob Bratislava Slovakia
Semmelweis University Budapest Hungary
Hospital Universitario De Cruces Barakaldo Spain
Kepler Universitaetsklinikum GmbH Linz Austria
Ospedale Pediatrico Bambino Gesu’ Rome Italy
Uizyvrahen Hravauby Cpwbpdc Cologne Germany
Ueradazizgybepzchbtgm Wsnipvclo Agc Wuerzburg Germany
Hvefwnla Vgfp dtzatlbi Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
03.05.2026
Belgium Belgium
Not yet recruiting
03.05.2026
Germany Germany
Recruiting
03.05.2026
Hungary Hungary
Not yet recruiting
03.05.2026
Italy Italy
Not yet recruiting
03.05.2026
Slovakia Slovakia
Not yet recruiting
03.05.2026
Spain Spain
Not yet recruiting
03.05.2026

Trial locations

Investigated drugs:

Romosozumab is an injectable medication being studied to see how safe it is for children and teenagers with osteogenesis imperfecta, a condition that affects bone strength. It is used to help manage the condition by acting on the processes that build and break down bone.

Investigated diseases:

Osteogenesis Imperfecta – This is a genetic condition that affects the development of bones. It is caused by problems with the production of collagen, which is a protein that provides strength and structure to the skeletal system. As the condition progresses, the bones become increasingly fragile and prone to breaking. The severity and speed of progression can vary significantly between individuals. Some people may experience frequent fractures starting from early childhood.

Trial ID:
2023-503293-21-00
Protocol code:
20220043
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Losartan and Hydrochlorothiazide for Osteogenesis Imperfecta in Patients Aged 16 and Above

    Recruiting

    2 1 1 1
    Investigated diseases:
    Italy
  • Study Comparing Setrusumab and Bisphosphonates for Children with Osteogenesis Imperfecta

    Not recruiting

    3 1 1 1
    Investigated diseases:
    France Germany Italy The Netherlands Poland