Study to Evaluate Efficacy and Safety of Romosozumab Compared With Bisphosphonates in Children and Adolescents With Osteogenesis Imperfecta

Inclusion Criteria:

• Participant has provided informed consent/assent prior to initiation of any studyspecific activities/procedures.

OR

• Participant's legally authorized representative has provided informed consent whenthe participant is legally too young to provide informed consent and the participanthas provided written assent based on local regulations and/or guidelines prior toany study-specific activities/procedures being initiated.

• Ambulatory male and female children and adolescents, age 5 to <18 years, includingambulatory with assistance as defined in the pediatric osteogenesis imperfecta (OI)population.

• Clinical diagnosis of OI, defined as clinical history consistent with type I, III,or IV OI as determined by presence of expected phenotype (examples include: facialshape, voice, blue sclera, dentinogenesis imperfecta, typical radiographic features,fracture pattern) and lack of additional features unrelated to type I, III, or IV OI (eg, blindness, mental retardation, neuropathy, and craniosynostosis). o If familial, also must be autosomal dominant.

• Meets at least one of the following:

• 3 or more fractures within the previous 2 years, or

• 1 or more nonvertebral fracture(s) within the previous 2 years and at least 1prevalent vertebral fracture, or

• 2 or more prevalent vertebral fractures.

Exclusion Criteria:

Disease Related

• History of an electrophoresis pattern inconsistent with type I, III or IV OI.

• History of known mutation in a gene other than collagen type I alpha 1/collagen typeI alpha 2 (COL1A1/COL1A2) causing OI or other metabolic bone disease.

• History of congenital dislocation of the radial head, interosseous membranecalcification, or exuberant callus formation.