Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 1 step.

  1. Step 1

    Safety follow-up phase

    After completing a previous study involving romosozumab, a period of monitoring begins to evaluate safety.

    This phase focuses on observing any adverse events, which are unexpected or harmful medical occurrences, in individuals with osteogenesis imperfecta, a condition that affects bone strength.

Who can join the trial?

5 criteria

  • 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 trial?

4 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

Romosozumab - This medication is administered as a liquid through a small needle injected just under the skin. It is an established treatment used to help increase bone density and strength in people with severe bone loss. The drug works by blocking a specific protein in the body that normally prevents bone from building up, which allows the body to create more bone mass. It is classified as a bone-building medication that acts on the body's bone-regulating processes.

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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-503293-21-00Protocol code20220043Estimated enrolment71 patientsSponsorAmgen Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.