Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial

Abstract

Objective: Investigate whether intervention with GH after tibial fracture enhances fracture healing. Design: Randomised, double-blind, placebo-controlled study in 406 patients (93 women, 313 men, age: 18-64 years) with tibial fracture. Methods: Patients were stratified by tibial fracture (open or closed) and allocated to placebo or GH treatment (15, 30 or 60 mg/kg daily, until clinically assessed healing or until 16 weeks post-surgery). Primary outcome was time from surgery until fracture healing and assessment of healing was done centrally and observer blinded. Patients reported for evaluation every 4 weeks until 24 weeks, and at 9 and 12 months.

Incorporação do hormônio do crescimento humano recombinante (rhGH) em matriz de polímero biodegradável

“…O uso do rhGH sistemicamente em fraturas ósseas já vem sendo estudado, como no trabalho de Raschke et al 18 , que utilizaram o rhGH sistemicamente em pacientes com fraturas de tíbia. Seus resultados mostraram a eficiência do rhGH na cicatrização óssea no grupo de pacientes que receberam um tratamento conservador, não cirúrgico.…”

Regeneración ósea en animales de experimentación, mediante cemento de fosfato cálcico en combinación con factores de crecimiento plaquetarios y hormona de crecimiento humana

“…Todos los autores coinciden en su efecto positivo sobre la curación de las fracturas, no obstante, la mayoría han reportado efectos sistémicos adversos 28,29 . Sin embargo, hay pocos estudios sobre su utilización local, y los que se han encontrado, no informan de efectos sistémicos 30 .…”

Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections

“…Detailed information on the study design and exposed study population has been reported previously [19]. Briefly, subjects were stratified by the type of fracture, i.e., open or closed.…”

“…The baseline characteristics across the treatment groups were similar, with the majority in each treatment group being Caucasian males with a closed tibia fracture; however, race was not recorded at the trial sites in South Africa, which contributed with approximately 30% of the trial population. Further details of the subject demography and accountability have been presented previously [19].…”