Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures
Status:
Completed
Trial end date:
2003-10-01
Target enrollment:
Participant gender:
Summary
This trial is conducted in Africa, Europe and Middle East. This trial investigates the
efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to
placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the
first part, the patients will be evaluated with regard to efficacy (fracture healing) and
safety at short time intervals until week 24 post-surgery. In the second part, long-term
safety and fracture healing up to 12 months post-surgery will be evaluated.