Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures

Novo Nordisk

Status and phase

Completed

Phase 2

Conditions

Tibia Fractures

Bone Fracture

Treatments

Drug: somatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00254514

NN1606-1365

Details and patient eligibility

About

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.

Enrollment

407 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)