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

Novo Nordisk A/S407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

407

Conditions

Bone Fracture Tibia Fractures

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)