BridgeMD
A Phase 3, Open-label, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Romosozumab Compared with Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta
EU CTIS ID: 2023-503294-37-00
What this study is testing
To evaluate the effect of romosozumab treatment for 12 months compared with bisphosphonate(s) on the number of clinical fractures at 12 months (FDA); the number of any fractures at 12 months and change in lumbar spine BMD Z-score at 12 months (EMA)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female subjects 5 to less than 18 years of age with a diagnosis and 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). - If familial, also must be autosomal dominant. Note: genetic testing is not required; however, if result is available, it should be consistent with type I, III, or IV.
- Meets at least one of the following: - 3 or more fractures within the previous 2 years, or -1 or more nonvertebral fracture(s) within the previous 2 years and at least 1 prevalent vertebral fracture, or -2 or more prevalent vertebral fractures.
You likely can't join if
- History of an electrophoresis pattern inconsistent with type I, III or IV OI.
- History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.
- History of congenital dislocation of the radial head, interosseous membrane calcification, or exuberant callus formation.
- Use of concomitant medications that may prolong QT interval within 1 month prior to screening will be reviewed by the Principal Investigator and the Medical Monitor. Written documentation of this review is required for subject participation. Refer to Crediblemeds.org for the complete list of medications which can impact QT interval.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Australia
- Canada
- United Kingdom
- United States
- Switzerland
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Australia; Canada; United Kingdom; United States; Switzerland and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.