Intranasal administration of growth hormone-releasing hormone(1-29)-NH2 in children with growth hormone deficiency: effects on growth hormone secretion and growth

Acta Paediatr Suppl. 1993 Mar:388:23-6; discussion 27. doi: 10.1111/j.1651-2227.1993.tb12830.x.

Abstract

The growth-promoting potential of growth hormone-releasing hormone(1-29)-NH2 (GHRH(1-29)-NH2) in a new formulation for intranasal use was examined in a 6-month pilot study of eight short prepubertal children. The maximal plasma concentration of growth hormone (GH) was below 12 micrograms/l in two stimulation tests (arginine, insulin), but above 12 (24-90) micrograms/l after intravenous GHRH, 1 microgram/kg. GHRH, 50 micrograms/kg, was insufflated intranasally three times per day over 6 months. On day 1, GHRH insufflations were followed by distinct GHRH and GH plasma peaks, ranging from 1.2 to 5.4 micrograms/l and from 10 to 85 mIU/l, respectively. Peak amplitudes were variably reduced after 6 weeks in most patients, and further reduced at 6 months. GHRH antibodies (initially negative) were positive in three patients after 6 weeks. The mean knemometric growth rate rose from 0.24 to 0.48 mm/week after 6 weeks of treatment (p = 0.03) and then rapidly declined; the mean 6-month stadiometric height velocity did not increase. Local tolerance was good in one patient; most others reported sneezing immediately after insufflation, rhinorrhoea and mild mucosal burning. Treatment was discontinued in two patients after 6 and 12 weeks. It is concluded that intranasal GHRH, though non-invasive, is not suitable in its present form for use in children, because of decreasing absorption and effectiveness with concomitant development of antibodies and local reactions.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Intranasal
  • Age Determination by Skeleton
  • Body Height / drug effects
  • Body Weight / drug effects
  • Child
  • Female
  • Growth Disorders / blood
  • Growth Disorders / diagnosis
  • Growth Disorders / drug therapy*
  • Growth Disorders / etiology
  • Growth Hormone / blood
  • Growth Hormone / deficiency*
  • Growth Hormone / drug effects
  • Growth Hormone / metabolism
  • Humans
  • Injections, Intravenous
  • Insulin-Like Growth Factor I / analysis
  • Leg / growth & development
  • Male
  • Pilot Projects
  • Rhinitis / chemically induced
  • Sermorelin / administration & dosage*
  • Sermorelin / blood
  • Sermorelin / pharmacology
  • Sermorelin / therapeutic use

Substances

  • Insulin-Like Growth Factor I
  • Sermorelin
  • Growth Hormone