Osteogenesis ImperfectaPhase 3NCT07366086
Pediatric Safety Follow-up Study of Prior Treatment With Romosozumab for Osteogenesis Imperfecta
A Phase 3 study testing Vitamin D and Calcium in people with Osteogenesis Imperfecta, run by Amgen at 4 sites in 3 countries.
Trial summary
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early. Read more about this study
- Who is it for?
- Ages 5 to 19 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Vitamin D and Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 18 Mar 2026to 19 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant has provided informed consent/assent prior to initiation of any trial specific activities/procedures.
- OR 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 trial-specific activities/procedures being initiated.
- Participant was randomized to the romosozumab arm and completed Trial 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.
Who cannot join
- Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on another investigational device or drug trial(ies) with the exception of trial 20200105. Other investigational procedures while participating in this trial are excluded.
- Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Germany2 sites, 2 recruiting
- Recruiting
Universitaetsklinikum Koeln
Cologne, 50937
- Recruiting
Universitaetsklinikum Wuerzburg
Würzburg, 97074
United States1 site, 1 recruiting
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Japan1 site, 1 recruiting
- Recruiting
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, 700-0013
About this study
Official title: Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Vitamin D, Calcium
- Keywords
- Romosozumab, EVENITY
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Participants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance.
CalciumDietary supplement
Participants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Participants who completed romosozumab trial 20200105 will continue to receive standard of care treatment (calcium and vitamin D), as determined by the investigator and local guidance. No investigational drug product will be administered in this trial as this is a safety follow-up. Receives: Dietary Supplement: Vitamin D; Dietary Supplement: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start18 Mar 2026
- Primary completion19 Apr 2028 (estimated)
- Study completion19 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366086
- Sponsor's protocol ID
- 20220043
- Other IDs
- 2023-503293-21-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 5 Jan 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Safety Follow-up Study to Assess Safety of Prior Treatment With Romosozumab in Children and Adolescents With Osteogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT07366086
- Acronym / sponsor ID
- 20220043
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Romosozumab, EVENITY
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 19 Apr 2028 (estimated)
- Study completion
- 19 Apr 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to evaluate the safety of romosozumab in participants with osteogenesis imperfecta (OI) that have completed Study 20200105, regardless of whether they received investigational product (romosozumab) until the last protocol-specified dose or ended investigational product early.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Dietary Supplement: Vitamin D, Dietary Supplement: CalciumParticipants who completed romosozumab trial 20200105 will continue to receive standard of care treatment (calcium and vitamin D), as determined by the investigator and local guidance. No investigational drug product will be administered in this trial as this is a safety follow-up. |
Who may qualify
- Ages
- 5 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participant has provided informed consent/assent prior to initiation of any trial specific activities/procedures.
- OR 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 trial-specific activities/procedures being initiated.
- Participant was randomized to the romosozumab arm and completed Trial 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.
Key exclusion criteria (2 listed)
- Currently receiving treatment in another investigational device or drug trial, or less than 2 years since ending treatment on another investigational device or drug trial(ies) with the exception of trial 20200105. Other investigational procedures while participating in this trial are excluded.
- Participant likely to not be available to complete all protocol-required trial visits or procedures, and/or to comply with all required trial procedures to the best of the participant and investigator's knowledge.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DParticipants are recommended to receive Vitamin D supplements as standard of care treatment, per investigator discretion and local guidance. | Dietary supplement | Standard of Care |
| CalciumParticipants are recommended to receive Calcium supplements as standard of care treatment, per investigator discretion and local guidance. | Dietary supplement | Standard of Care |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Related trials for Osteogenesis Imperfecta
RecruitingPhase 2
Osteogenesis Imperfecta Trial of AGA2115 for ADUlts With COL1A1 and/or COL1A2 GeNetic Variations (IDUN)
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Active, not recruitingObservational study
Cardiopulmonary Outcomes in Osteogenesis Imperfecta: BBD7708
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Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
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Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta
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Setrusumab vs Placebo for Osteogenesis Imperfecta
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D and Calcium in people with Osteogenesis Imperfecta, run by Amgen at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.