Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Exclusion Criteria

• •History of an electrophoresis pattern inconsistent with type I to type IV OI
• •History of known mutation in a gene other than collagen type I alpha 1/collagen type I alpha 2 (COL1AI/COL1A2) causing OI or other metabolic bone disease
• •History of other bone diseases that affect bone metabolism (eg, osteoporosis pseudoglioma syndrome, idiopathic juvenile osteoporosis, osteopetrosis, hypophosphatasia)
• •History of Kawasaki disease, rheumatic myocarditis, ischemic cardiomyopathy, inherited cardiomyopathies, nephrotic syndrome, familial hypercholesterolemia, stroke, or any thromboembolic disorder
• •Unhealed fracture as defined by orthopedic opinion
• •Symptoms associated with skull abnormalities such as basilar invagination, basilar impression or Chiari malformation
• •Prior treatment with anti-sclerostin antibody, fluoride or strontium, parathyroid hormone (PTH) within 12 months prior to screening, denosumab within 12 months or zoledronic acid within 6 months prior to first dose
• •Less than 2 evaluable vertebrae by DXA evaluation in the region of interest, L1 - L4, as confirmed by the central imaging laboratory.
• •Clinically significant valvular heart disease based on local echocardiogram (ECHO) results.