Even Without a Deficiency, Growth Hormone Makes Short-Stature Kids Taller
Growth hormone started as late as puberty onset can help children with idiopathic short stature reach their full height potential, researchers here confirmed.
Growth hormone for children who are not deficient in it resulted in more than a standard deviation increase in height compared with nontreatment for a final height that was significantly closer to the population-based norm on average (both P<0.001), found Kerstin Albertsson-Wikland, M.D., Ph.D., of the University of Gothenburg here, and colleagues.
In the randomized dose-response trial, growth response was the same for those without growth hormone deficiency whether they had idiopathic short stature or failed to catch-up to their peers after being born small for gestational age, the investigators reported in the November issue of the Journal of Clinical Endocrinology & Metabolism.
Various growth hormone products are approved for children with growth hormone deficiency, Turner syndrome, and other causes of short stature. This week, a growth hormone product — injectable somatropin (Norditropin [rDNA origin]) — received FDA approval for treatment of short stature in children born small for their gestational age without catch-up growth by age two to four years.
But growth hormone therapy still cannot be universally recommended for children with idiopathic short stature, the researchers cautioned.
“On the contrary,” they wrote, “it should be recommended to those predicted to have a good growth response, and only after thorough discussions with the subjects and parents to determine, on a case-by-case basis, those who suffer substantially from their short stature.”
When natural growth hormone hit the market in the 1950, a limited supply restricted its use to only children with severe growth hormone deficits.
Even after a biosynthetic form became available in the late 1980s, evidence for use in children without growth hormone deficiency was limited, particularly for those with idiopathic short stature.
Trial data for this population is still not of consistently high quality, with some studies lacking randomized control groups and others following only a limited number of children to final height.
The current dose-response study included 177 children more than two standard deviations below the Swedish norm but with normal growth hormone levels (maximum value below 10 Î¼g/L at two stimulation tests) and without other known causes of short stature.
None was born before 35 weeks of gestation or with extreme intrauterine growth retardation.
At baseline, girls were age eight to 13 years with a bone age of no more than 11 years by Tanner-Whitehouse criteria. Boys were ages 10 to 15 with a corresponding bone age of no more than 13 years.
These children were followed for one year and those who had not started puberty were randomized to no treatment or 33 Î¼g/kg or 67 Î¼g/kg of growth hormone (Genotropin) per day.
Children who entered puberty were likewise randomized to no treatment or the higher dose of growth hormone until they reached their final height defined by a growth velocity of less than 1 cm per year (average 5.9 years).
Final height was significantly taller among growth hormone-treated patients overall in the per protocol population compared with no treatment:
- 1.5 versus 2.4 standard deviations below the population-based norm (P<0.001)
- 0.2 versus 1.0 standard deviations below mean parental height (P<0.001)
- 1.3 versus 0.2 standard deviations gain in height (P<0.001)
Height gains showed a dose-response relationship with growth hormone that began within one year for all growth endpoints and populations. Final height was 1.7 below normal with 33 Î¼g/kg/d versus 1.4 with 67 Î¼g/kg/d (P<0.032).
Boys had greater treatment response to growth hormone than girls, although both groups saw significant gains compared with controls.
Children with idiopathic short stature had significant benefits in all measures of height with growth hormone for both boys and girls compared with untreated controls.
However, children born into short families, defined by a mean parental height at least two standard deviations below normal in Sweden, had significantly less growth response to hormone therapy.
Growth hormone had no impact on the time to onset of puberty compared with nontreatment (mean 22.6 versus 22.2 months after start of the study).
The researchers called growth hormone therapy safe in their study with no serious adverse events attributed to it, effects on thyroid or liver function, or persistent elevations in glucose and insulin levels.
Withdrawals due to adverse events included once case each of dissociative identity disorder, pituitary cyst, mood swings, and irritability in the growth hormone group and one case of brain cancer and a traffic accident in the untreated control group.
All intent-to-treat findings were similar to those for the per-protocol analyses.
The original article can be found at www.medpagetoday.com
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