Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature
The present randomized trial was initially intended to study the benefits of a combined
 treatment with growth hormone (GH) and a gonadotropin-releasing hormone (GnRH) agonist for
 pubertal children with idiopathic short stature. However, treatments were stopped in January
 2012 at the request of the French drug agency. Therefore, a protocol amendment divided the
 study in two study periods.

 Study Period 1 involved combined treatment with somatropin and leuprorelin or treatment with
 somatropin alone. Participants from France who participated in this Period 1 of the study
 were asked to participate in a long term safety follow up defined as a Period 2 of the study.
 Participants from the Netherlands were offered participation in Genetics and
 Neuroendocrinology of Short Stature International Study (GeNeSIS, clinicaltrials.gov
 Identifier: NCT01088412) for long term safety follow up independent of this study.
Inclusion Criteria:

 -  male or female children with ISS

 -  age greater than or equal to 8 years and less than or equal to 12 years and 3 months
 for girls and greater than or equal to 9 years and less than or equal to 14 years and
 3 months for boys

 -  bone age less than or equal to 12.0 years for girls and less than or equal to 14.0
 years for boys based on a central reading of an X-ray of the left hand and wrist

 -  Pubertal stage B2 and B3 for girls based on the Tanner method

 -  Pubertal stage G2 and G3 for boys based on the Tanner method

 Exclusion Criteria:

 -  Growth hormone deficiency (GHD)

 -  Insulin-like growth factor-I levels greater than 3 SDS

 -  Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype to
 eliminate a Turner syndrome, is mandatory

 -  Small for gestational age (SGA)

 -  Has reached menarche (had her first menstrual period)

 -  Have any significant concomitant disease that is likely to interfere with growth or
 with the study, or is a known contraindication to Growth Hormone treatment