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

• Status: Completed
• Trial end date: 2013-05-10
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: UCB Pharma
• Treatments: Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates

• Fresh unilateral closed or Gustilo type I or type II open tibial fracture

• Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) 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