Bone Fracture, Tibia Fractures
Conditions
Brief 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.
Interventions
DRUGsomatropin
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Primary surgical treatment of tibia fracture using intramedullary nailing * Closed fractures: Tscherne Type C1, C2 and C3 * Open fractures: Gustilo Grade I, II and IIIa
Exclusion criteria
* Open growth plate on X-rays * Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 \> 32.0 * Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry * Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from surgery until fracture has healed | During a 12 month period |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's assessment: fracture healed | — |
| Number of fractures healed | — |
Countries
Finland, France, Germany, Hungary, Israel, Norway, Poland, South Africa, Spain
Outcome results
None listed