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

Condition(s) targeted: Tibia Fractures

Intervention: Somatropin (Norditropin® SimpleXx®) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Anders Dejgaard, MD, Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Africa, Europe & 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.

Official title: Efficacy and Safety of Growth Hormone (Norditropin® SimpleXx®) on Fracture Healing in Tibia Fractures Treated Surgically With Intramedullary Nailing

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time from surgery until fracture has healed during a 12 month period.

Secondary outcome:

Investigator’s assessment: fracture healed

Number of fractures healed

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

enlargment 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)

Charité, Campus Virchow Unfallchirurgie, Berlin, Germany

Soroko Medical Center, Beer Sheva, Israel

Tygerberg Hospital, Cape Town, South Africa

Starting date: August 2001
Last updated: November 15, 2006