Study of AMG 785 in Tibial Diaphyseal Fractures Status Post Intramedullary Nailing
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | September 2009 |
| End Date: | September 2013 |
| Contact: | Amgen Call Center |
| Phone: | 866-572-6436 |
A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
This is an international, multi-center, randomized, double blind, placebo controlled study
of AMG 785 in skeletally mature adults with a fresh unilateral tibial diaphyseal fracture
status post a definitive fracture fixation with an intramedullary (IM) nail. The primary
hypothesis for this study is that AMG 785 compared with placebo is effective in reducing
radiographic healing time of fresh tibial diaphyseal fractures.
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
We found this trial at
11
sites
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