Use of human GH in elderly patients with accidental hip fracture.

OBJECTIVE: To investigate whether early intervention with recombinant human growth hormone (hGH) after hip fracture improves functional recovery and long-term outcome. SUBJECTS AND METHODS: Functional recovery after hip fracture is often incomplete. The catabolic situation that develops after the hip fracture accident, and a state of malnutrition either pre-existing or developing after surgery, are main contributing factors for the poor clinical outcome. hGH has been used to promote anabolism in a variety of clinical catabolic situations. The study design was randomized, double-blind and placebo-controlled. A total of 111 patients older than 60 years with an accidental hip fracture (mean age 78.5+/-9.1 (s.d.) years) were randomized to receive either hGH (20 microg/kg per day) or placebo for a period of 6 weeks, starting within 24 h after the hip fracture accident. Thereafter patients were followed up for an additional period of 18 weeks. Efficacy was assessed by comparing the changes in the Barthel Index score of activities of daily living and in a patient's living situation between the hGH- and the placebo-treated subjects.
RESULTS: Eighty-five (78.5%) patients completed the first 8 weeks of the study and 76 (68.5%) the entire study period of 24 weeks. When split according to age, a trend was found that for patients older than 75 years the changes in Barthel Index score from baseline were less in the hGH group than in the placebo group (-18.6+/-18 vs -28.1+/-26) at 6 weeks after surgery (P<0.075). There was an overall trend to a higher rate of return to the pre-fracture independent living situation in the hGH group than in the placebo group. Analysis by age revealed a significantly higher proportion of hGH- than placebo-treated patients returning to the pre-fracture living situation for subjects older than 75 years (93.8 vs 75.0%, P=0.034). hGH treatment increased IGF-I values to levels in the range of those of normal subjects of 50-60 years of age.
CONCLUSIONS: A 6 week treatment with hGH (20 microg/kg per day) of otherwise healthy patients after an accidental hip fracture may be of benefit if given to subjects older than 75 years of age. The rate of return to the pre-fracture living situation in subjects of this age treated with hGH was significantly increased when compared with the placebo-treated group. The treatment intervention was well tolerated and no safety issues were recorded.

RCT Entities:   Population Interventions Outcomes