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

Phase 4 Completed 115 enrolled Merck KGaA, Darmstadt, Germany

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 1992-02-29
Primary completion: 1999-03-31
Completion: 2010-08-31

Outcome

Met primary endpoint

paper in contrast to the decrease in mean H-SDS of 0.3 SDS in the control group (from -2.09±0.81 to -2.44±0.73 SDS; P<0.0001). PMID 21398400 ↗

Publications

Results Linglart A, Cabrol S, Berlier P, Stuckens C, Wagner K, de Kerdanet M, Limoni C, Carel JC, Chaussain JL; French Collaborative Young Turner Study Group. Growth hormone treatment before the age of 4 years prevents short stature in young girls with Turner syndrome. Eur J Endocrinol. 2011 Jun;164(6):891-7. doi: 10.1530/EJE-10-1048. Epub 2011 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	recombinant human GH	Protein / enzyme biologic	0.035 mg/kg	Subcutaneous
Subject	recombinant human GH	Protein / enzyme biologic	0.05 mg/kg	Subcutaneous