Methodology and implications of knemometry in growth assessment of inhaled glucocorticoids

Pediatr Allergy Immunol. 2010 Feb;21(1 Pt 2):e190-8. doi: 10.1111/j.1399-3038.2009.00882.x. Epub 2009 May 4.

Abstract

When validated recommendations for standardization and measurement procedures are used short-term assessment of lower leg growth by knemometry is a highly accurate and reproducible method for assessment of systemic activity of inhaled glucocorticoids. Crossover and parallel designs applying consistent measurement intervals can be used. Crossover designs with a single-blind run in and washout and double-blind active periods are as sensitive as designs using randomized placebo periods. In populations of children, short-term knemometry appears to be capable of defining specific glucocorticoids, application devices and doses that do not suppress long-term height growth. Although no specific cut-off level can be identified in individuals from the available randomized, double-blind short-term knemometry and intermediate-term height growth rate studies, good evidence have been provided that if the short-term lower leg growth suppression in populations of children is higher than approximately 25%, the risk of intermediate-term growth suppression becomes significant with a mean height growth rate retardation in the range of approximately 0.5-1.5 cm during the first year of treatment. Short-term knemometry should be performed as an integral part of the safety assessments of new inhaled glucocorticoids and inhalation devices in children with asthma, before intermediate-term height growth evaluations are initiated.

Publication types

  • Review

MeSH terms

  • Administration, Inhalation
  • Animals
  • Asthma / drug therapy*
  • Asthma / physiopathology*
  • Child
  • Cross-Over Studies
  • Double-Blind Method
  • Glucocorticoids / administration & dosage*
  • Glucocorticoids / adverse effects
  • Growth and Development / drug effects
  • Humans
  • Leg Bones / anatomy & histology*
  • Leg Bones / drug effects
  • Leg Bones / growth & development
  • Monitoring, Physiologic* / methods
  • Monitoring, Physiologic* / trends
  • Single-Blind Method

Substances

  • Glucocorticoids