A Phase 3 interventional study of Romosozumab and Bisphosphonate in Osteogenesis Imperfecta, sponsored by Amgen. Active, not recruiting at 65 sites in 18 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the number of clinical fractures at 12-months; the number of any fractures at 12-months and change in lumbar spine bone mineral density (BMD) Z-score at 6-months.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's enrollment of 111 is above the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →Amgen is the lead sponsor of 1,047 studies on the registry; 52 are open to participants now.
Of its 246 completed or terminated interventional studies of FDA-regulated products, 166 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
OR
Clinical diagnosis of OI, defined as clinical history consistent with type I, III, or IV OI as determined by presence of expected phenotype (examples include: facial shape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features, fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis).
o If familial, also must be autosomal dominant.
Meets at least one of the following:
Exclusion Criteria:
Disease Related
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive romosozumab once a month (QM) for 12 months.
Drug: Romosozumab
Participants will receive bisphosphonates per local standard of care treatment regimens, as determined by the investigator for 12 months.
Drug: Bisphosphonate
Subcutaneous (SC) injection
Also known as: EVENITY®
Administration determined by investigator according to the local standard of care
Number of Clinical Fractures
Clinical fractures include clinical vertebral fractures and nonvertebral fractures.
Time frame: 12 months
Number of Any Fractures
Fractures include new and worsening vertebral compression fractures, whether clinically silent or manifest, and nonvertebral fractures.
Time frame: 12 months
Change from Baseline in Lumbar Spine BMD Z-score at 12 Months, as assessed by DXA
Time frame: Baseline and 12 months
Change from Baseline in lumbar spine BMD Z-score at 6 months and 12 months, as assessed by DXA
Time frame: Baseline, 6 months, and 12 months
Change from Baseline in Total Hip BMD Z-score at 6 Months and at 12 Months, as assessed by DXA
Time frame: Baseline, 6 months, and 12 months
Change from Baseline in Femoral Neck BMD Z-score at 6 Months and at 12 Months, as assessed by DXA
Time frame: Baseline, 6 months, and 12 months
Number of Participants with Any Fractures
Time frame: 12 months
Number of Participants with Clinical Fractures
Time frame: 12 months
Number of Participants with New or Worsening Vertebral Fractures
Time frame: 12 months
Number of Participants with Nonvertebral Fractures
Time frame: 12 months
Number of Participants with Long Bone Fractures
Time frame: 12 months
Number of New or Worsening Vertebral Fractures
Time frame: 12 months
Number of Nonvertebral Fractures
Time frame: 12 months
Number of Long Bone Fractures
Time frame: 12 months
Change from Baseline in Child Health Questionnaire - Parent Version (CHQ-PF-50) Physical Summary Score
The CHQ-PF-50 measures how a child's condition affects their ability to function in daily life. The CHQ-PF-50 measures 50 items in the following domains: physical functioning, role/social limitations - physical, general health perceptions, bodily pain/discomfort, family activities, role/social limitations - emotional/behavioral, parent impact - time, parent impact - emotion, self-esteem, mental health, behavior, family cohesion, change in health. Each item is rated on a scale from "without any difficulty" to "unable to do". Total scores for each item are transformed to 0 - 100 scale, with lower scores indicating worse health states. Higher change from baseline scores indicate better or more positive health states.
Time frame: Baseline and 12 months
Change from Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Score
The CHAQ measures how a child's condition affects their ability to function in daily life. The CHAQ measures 50 items in the following domains: physical functioning, role/social limitations - physical, general health perceptions, bodily pain/discomfort, family activities, role/social limitations emotional/behavioral, self-esteem, mental health, behavior, family cohesion, change in health. Each item is rated on a scale from "without any difficulty" to "unable to do". Total scores for each item are transformed to 0 - 100 scale, with lower scores indicating worse health states. Higher change from baseline scores indicate better or more positive health states.
Time frame: Baseline and 12 months
Change from Baseline in the Wong-Baker Faces Pain Rating Scale
The Wong-Baker Faces Pain Rating Scale is a horizontal pain scale that consists of six hand-drawn faces that range from a smiling "no hurt" face with a score of 0 to a crying "hurts worst" face with a score of 10. Greater change from baseline scores indicate greater pain experienced by the participant.
Time frame: Baseline and 12 months
Serum Concentration of Romosozumab
Time frame: Day 1 to Month 12
Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) at 12 Months
Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.
Time frame: 12 months
Number of Participants who Experience TEAEs from Month 12 to Month 15
Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.
Time frame: Month 12 to Month 15
Number of Participants with Anti-drug Antibodies (ADA) to Romosozumab
Time frame: Up to 15 months
Number of Participants who Experience TEAEs at 15 Months
Any clinically signification change from baseline in laboratory values and vital signs after first dose will be recorded as a TEAE.
Time frame: 15 months
Number of Participants with a Narrowing from Baseline to 6 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull
Measured in a subset of participants who receive cranial nerve computerized tomography (CT) scans.
Time frame: Baseline and 6 months
Number of Participants with a Narrowing from Baseline to 12 Months in the Intracranial Nerve Tract in the Cranium and Vault of the Skull
Measured in a subset of participants who receive cranial nerve CT scans.
Time frame: Baseline and 12 months
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Data sharing details ↗ · www.amgen.com
Started Apr 2024 (actual). Primary completion is estimated for May 2027, 36 months after the start.
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This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Romosozumab