Clinical Trial Involving Monthly Injections for Osteogenesis Imperfecta (OI)
Purpose
The reason for this study is to see if the investigational drug, called AGA2115, can help increase bone mineral density in people with osteogenesis imperfecta. AGA2115 or a placebo drug will be given at the clinic once a month subcutaneously. During this study, changes in bone biomarkers, number of bone fractures, and quality of life, will be measured to see if AGA2115 can help people with osteogenesis imperfecta. This study will also look at how the body absorbs, breaks down and gets rid of AGA2115 (called pharmacokinetics), if AGA2115 affects any markers of bone metabolism in the body, if the body’s natural defense system (the immune system) tries to make antibodies to AGA2115 (called immunogenicity) and how well people feel while taking AGA2115, including any side effects they may have.
You will be asked to complete the following: perform monthly injections, take Vitamin D and Calcium supplements, perform ECGs and DEXA scans, provide blood samples, perform grip strength tests, do hearing tests (called Audiometry and Tympanometry), complete questionnaires, undergo a one-time bone biopsy, and see the study doctor.
If you do not have genetic confirmation of osteogenesis imperfecta, we may be able to test for it through the study.
The study will last 27 months.
Could this study be right for you?
The most important eligibility criteria include the following. This is not an expansive list.
- Genetic confirmation of Osteogenesis Imperfecta Type I, III, or IV diagnosis
- DXA scan assessing L1-L4 region
- BMD T-score <= -1.0 at lumber spine OR total hip OR femoral neck
- Cannot be taking IV or oral bisphosphonate with the past 6 months