Growth Hormone Treatment for the Prevention of Short Stature in Young Girls With Turner Syndrome Before the Age of 4 Years

• Status: Completed
• Trial end date: 2010-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to evaluate the efficacy and safety of recombinant human growth hormone (r-hGH) treatment in girls with Turner Syndrome under the age of 4 years. After 4 years of treatment, height in these girls will be compared with an historical control group of untreated girls with Turner Syndrome, matched for age and height at baseline.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA, Darmstadt, Germany
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Young girls with turner syndrome proved by karyotype

• Growth hormone secretion confirmed with ornithin stimulation test

• Normal glucidic metabolism confirmed by assessment of HbA1c

• None associated severe pathology which could have impact on growth (i.e. renal insufficiency, decompensated heart failure)

• No previous or associated treatment with anabolic or sexual steroids

• Known parental height

Exclusion Criteria:

• Severe associated pathology with impact on growth

• Concomitant treatment with impact on growth

• Previous or associated treatment with anabolic steroids

• Associated growth hormone deficiency