Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing

Exclusion Criteria

• •Major polytrauma or significant axial trauma
• •Associated lower extremity fracture that will delay subject's ability to bear weight beyond the normal time expected for a tibial shaft fracture
• •Use of bone grafts at the time of fracture fixation
• •Pathological fracture or metabolic or bone disease
• •History of symptomatic spinal stenosis or facial nerve paralysis
• •Malignancy within the last 5 years
• •Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
• •Use of agents affecting bone metabolism
• •Subject refuses to use appropriate methods of contraception