Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta
Multicenter Study to Evaluate Safety of Fresolimumab in Adults With Moderate-to-severe Osteogenesis Imperfecta
Researchers in OR and TX seek participants for a trial of an investigatory drug, Fresolimumab, for Osteogenesis Imperfecta. TGF-β is a protein important in bone formation. Studies have shown that increased TGF-β activity leads to lower bone mass and strength and increased fractures. Fresolimumab is an antibody that can silence TGF-β. This study seeks to explore the best dosage for the antibody: once, twice per year, or four times per year.
The study will require only visits for the injection of the drug and physical and lab assessments, for the frequency assigned over 12-month period.
- Be 18 years of age or older
- Have confirmed diagnosis of moderate-to-severe OI
- Meet genetic screening requirements
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Antibody infusion at each study visit, along with physical and lab assessments.
- Visits will be required a maximum of 4 times in a 12 month period.
LOCATIONS AND CONTACTS:
Contact: Dianne Dang | 713-798-6694 | [email protected]
Baylor College of Medicine
Genzyme, a Sanofi Company
Shriners Hospitals for Children
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Hospital for Special Surgery, New York
University of California, Los Angeles
University of Nebraska
Oregon Health and Science University
University of South Florida
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