Sustained-release recombinant human growth hormone improved body composition and QoL in adults over 50 years with somatopause

Abstract

Context: The elderly experiencing somatopause and the resultant metabolic impairment can obtain partial recovery from administration of recombinant human GH (rhGH). However, aged adults suffer inconvenience from daily injection of existing rhGH.

Objectives: To evaluate the effects, safety, and compliance of weekly administered low dose of sustained-release recombinant human GH (SR-rhGH) in aged adults with somatopause.

Design: This is a 26-week prospective, single-arm, multicenter phase IV trial in adults.

Intervention/Participants: A total of 38 subjects, aged ≥ 50 years with somatopause (serum IGF-1 < 150 ng/ml) were enrolled and each received 2 mg of SR-rhGH for 26 weeks.

Results: Mean baseline IGF-1 level of 123.4 ± 41.6 ng/ml increased to 174.8 ± 59.6 ng/ml after administration of SR-rhGH at 4 weeks and it was maintained for the remainder of the study period. At 26 weeks, average lean body mass increased by 0.45 kg, waist circumference reduced by 1.06 cm, and Quality of Life was improved significantly (P<0.01 in each index). There was a simultaneous increase in serum levels of biochemical markers of bone resorption and formation. Estrogen substitute in women attenuated the beneficial effects of SR-rhGH on body composition and metabolic indices. There was no significant change in the body fat distribution or fat mass. Adverse events included pruritus (10.5%), arthralgias (5.3%), and edema (5.3%), but their symptoms were well tolerable.

Conclusions: Body composition and Quality of Life can be restored in part by the replacement of low dose SR-rhGH for 26 weeks in patients with somatopause without significant adverse effects.