Use of human GH in elderly patients with accidental hip fracture

Abstract

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 78X5^9X1 (S.D.) years) were randomized to receive either hGH (20 mg/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 218X6^18 vs 228X1^26 at 6 weeks after surgery P , 0X075X 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 hGHthan placebo-treated patients returning to the pre-fracture living situation for subjects older than 75 years (93.8 vs 75.0%, P 0X034X 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 mg/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.

Translational Research on the Clinical Applications of Ghrelin

“…The age-related reduction in energy intake has been termed "the anorexia of aging" and predisposes to the development of under-nutrition, which has been implicated in the development and progression of chronic diseases commonly affecting the elderly, as well as in increasing mortality. Growth hormone therapy increases IGF-I levels, promotes anabolism and increases muscle strength in healthy elderly individuals, as well as in selected patient groups [48][49][50]. Therefore, ghrelin and GHS may also have therapeutic potential to assist in the recovery of frail patients who require nutritional support and conventional rehabilitation [51].…”

Osteoporosis and the Growth Hormone-Insulin-Like Growth Factor Axis

“…In a 2-year study in elderly women with low bone mass using cyclical rhGH, bone density increased in the spine by 3%, and lesser changes were found in the hip [62]. In elderly women over 75 years of age with a recent hip fracture, a 6-week treatment with rhGH significantly increased the chance of returning to their pre-fracture living situation, but no effect was found below 75 years of age [63]. …”

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

“…This was observed during both intramembranous bone formation and during secondary fracture healing, where bone formation is predominantly achieved by endochondral ossification (7)(8)(9)39 A previous study reported a very moderate effect in recovery of elderly patients with hip fractures receiving GH treatment, and this moderate effect might be ascribed to the short treatment duration (6 weeks) and the relatively low GH dose (i.e. 20 mg/kg per day) administered (1). In the present study, no significant enhancement of fracture healing effect was observed in open or closed fractures with 15 or 30 mg/kg, although an increase was observed at these dose levels with regard to levels of IGF-I and markers of bone remodelling.…”