Status:
COMPLETED
Study of Romosozumab (AMG 785) in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
Lead Sponsor:
Amgen
Collaborating Sponsors:
UCB Pharma
Conditions:
Fracture Healing
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2013
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00907296
Start Date
September 2 2009
End Date
May 10 2013
Last Update
September 22 2022
Active Locations (103)
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1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Orange, California, United States, 92868
3
Research Site
Aurora, Colorado, United States, 80012
4
Research Site
Denver, Colorado, United States, 80204