Safety of Fresolimumab in the Treatment of Osteogenesis Imperfecta

Exclusion Criteria

• •1. Fracture less than 3 months prior to the screening visit.
• •2. Rodding or instruments that prevents reliable bone mineral density (BMD) assessment.
• •3. Have a known unhealed fracture involving a long bone.
• •4. Do not meet laboratory safety requirements such as: Vitamin D \< 15 ng/dL Serum albumin-corrected calcium levels below 8 mg/dL, Hemoglobin \< 10 g/dL, Platelet count \< 75,000mm3;, Prothrombin time/(PT/INR) international normalized ratio \> 1.5 times Upper Limit of Normal (ULN), Clinical or laboratory abnormality of Grade III or higher as assessed by CTCAE v4.0 which in the view of investigator would compromise safety.
• •5. Have an EKG with QTc of \> 450 ms
• •6. Have a known allergy to fresolimumab.
• •7. Have current clinically significant infection.
• •8. Have a personal history of basal cell carcinoma, squamous cell carcinoma or keratoacanthomas, a personal history of cancer, recent or remote.
• •9. Have evidence of untreated cavities or planned invasive dental work during the study period.
• •10. Have had organ transplantation.
• •11. Have known or suspected valvular heart disease.
• •12. Plan to have skeletal surgery in the study period.
• •13. Have had osteotomy 5 months prior to the screening visit.
• •14. Being treated with zoledronic acid or pamidronate less than 12 months of screening OR oral bisphosphonates less than 6 months of screening OR teriparatide less than one year of screening.
• •15. Being treated with systemic glucocorticoids
• •16. Have autoimmune diseases being treated with glucocorticoids or other biologic agents.
• •17. Enrolled in another clinical trial and receiving treatment with another investigational agent
• •18. Pregnant or planning to get pregnant during the study period.
• •19. Nursing mothers.