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

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.

Timeline

Start

2001-08

Primary completion

2003-10

Completion

2003-10

Outcome

Missed primary endpoint

paper GH did not accelerate time to healing in the combined group of open and closed fractures. PMID 17322494 ↗

Publications

• Results Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51. doi: 10.1530/EJE-06-0598.
• Krusenstjerna-Hafstrom T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1.

Drugs

Indications