Romosozumab for Osteogenesis Imperfecta
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on assessing the safety of romosozumab, a medication used to strengthen bones, for individuals with osteogenesis imperfecta (OI), a condition that causes fragile bones. Participants who completed an earlier romosozumab study will receive standard care, including calcium and vitamin D, but no new investigational drugs. The trial seeks individuals who finished the previous study. Those who participated in the romosozumab arm of the earlier trial and completed it through the Month 15 Visit may be suitable for this safety follow-up. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for OI.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that romosozumab is likely to be safe for humans?
Research has shown that romosozumab is generally well-tolerated across different patient groups. Clinical studies demonstrated significant improvements in bone strength for those taking romosozumab, with bone density in the lower back increasing by 7.1% to 15.0% over three months. This indicates the treatment effectively strengthens bones.
Romosozumab is also approved for treating osteoporosis in postmenopausal women, suggesting its safety for at least some patients.
However, like any medication, it may cause side effects. While the studies did not specify side effects, FDA approval for another condition implies that safety risks are likely well-documented.
Prospective trial participants should consult their healthcare provider to understand any potential risks or side effects related to their health.12345Why are researchers excited about this trial?
Unlike the standard of care for osteogenesis imperfecta, which typically involves calcium and vitamin D supplements, romosozumab offers a new approach by targeting the underlying bone formation process. Romosozumab is a monoclonal antibody that works by inhibiting sclerostin, a protein that limits bone growth. This unique mechanism promotes bone formation and increases bone density, potentially offering more robust and faster improvements in bone strength compared to traditional supplements. Researchers are excited about romosozumab because it could represent a significant advance in treating this condition, providing new hope for improving quality of life for those affected.
What evidence suggests that romosozumab might be an effective treatment for osteogenesis imperfecta?
Studies have shown that romosozumab can greatly improve bone strength, particularly in the spine and hip. In individuals with osteoporosis, it has increased bone mineral density (BMD), helping to prevent fractures. For those with brittle bone disease (osteogenesis imperfecta), romosozumab has demonstrated promising results by enhancing bone quality. It strengthens bones by blocking a protein that slows bone growth. Early research suggests it could effectively boost bone strength in conditions like brittle bone disease. Participants in this trial will continue to receive standard care, including calcium and vitamin D, as determined by the investigator and local guidance.25678
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for children and teens with osteogenesis imperfecta who took part in a previous study (20200105) involving romosozumab, whether or not they finished all doses. Participants must have given consent or assent as required by local rules.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Follow-up
Participants are monitored for safety after completing prior treatment with romosozumab
Standard of Care
Participants continue to receive standard of care treatment (calcium and vitamin D) as determined by the investigator
What Are the Treatments Tested in This Trial?
Interventions
- Romosozumab
Trial Overview
The study is monitoring the long-term safety of prior treatment with romosozumab in young people with brittle bone disease (OI). All participants receive standard supplements like vitamin D and calcium. No new experimental drugs are being tested.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Citations
Osteoporosis Improved by Romosozumab Therapy in a ... - PMC
Our patient's improvement in BMD of the spine and right hip after romosozumab therapy was significant at a 95% confidence level, compared to treatment ...
Study to Evaluate Efficacy and Safety of Romosozumab ...
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 ...
3.
research-studies.allinforhealth.info
research-studies.allinforhealth.info/us/en/listing/12705/a-phase-3-open-label-2/A Phase 3, Open-label, Multicenter, Randomized Study to
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the ...
NCT05972551 | Study to Evaluate Efficacy and Safety of ...
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 ...
Erik Imel, MD - Indiana University School of Medicine
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 ...
Diala El-Maouche - PMC - NIH
The lumbar spine aBMD mean percentage increase from baseline to day 169 after 3 months of treatment ranged from 7.1% to 15.0% in adolescents and 7.1% to 12.7% ...
Study To Evaluate Efficacy And Safety Of Romosozumab ...
The primary objective of this study is to evaluate the effect of romosozumab treatment for 12-months compared with bisphosphonate(s) on the ...
8.
clinicaltrial.be
clinicaltrial.be/en/details/434197?per_page=20&only_recruiting=0&only_eligible=0&only_active=0Study to Evaluate Efficacy and Safety of Romosozumab ...
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 ...
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