Somatropin Treatment to Final Height in Turner Syndrome

Summary

A randomized, controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry, to determine the efficacy and safety of Humatrope (somatropin) treatment in promoting linear growth to final height.

Timeline

Start

1989-02

Primary completion

2007-12

Completion

2007-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); As-Randomized Control vs As-Randomized Humatrope; p <0.001; Mean Difference (Final Values) 0.9 (95% CI 0.7 to 1.1); ANCOVA NCT00191113 ↗

registry analysis (superiority or other test); As-Treated No Growth Hormone vs As-Treated Growth Hormone; p <0.001; Mean Difference (Final Values) 1.0 (95% CI 0.9 to 1.2); ANCOVA NCT00191113 ↗

Publications

• Background Lyon AJ, Preece MA, Grant DB. Growth curve for girls with Turner syndrome. Arch Dis Child. 1985 Oct;60(10):932-5. doi: 10.1136/adc.60.10.932.
• Background Kuczmarski RJ, Ogden CL, Grummer-Strawn LM, Flegal KM, Guo SS, Wei R, Mei Z, Curtin LR, Roche AF, Johnson CL. CDC growth charts: United States. Adv Data. 2000 Jun 8;(314):1-27.
• Results Hamelin CE, Anglin G, Quigley CA, Deal CL. Genomic imprinting in Turner syndrome: effects on response to growth hormone and on risk of sensorineural hearing loss. J Clin Endocrinol Metab. 2006 Aug;91(8):3002-10. doi: 10.1210/jc.2006-0490. Epub 2006 Jun 6.
• Results Stephure DK; Canadian Growth Hormone Advisory Committee. Impact of growth hormone supplementation on adult height in turner syndrome: results of the Canadian randomized controlled trial. J Clin Endocrinol Metab. 2005 Jun;90(6):3360-6. doi: 10.1210/jc.2004-2187. Epub 2005 Mar 22.
• Taback SP, Van Vliet G. Health-related quality of life of young adults with Turner syndrome following a long-term randomized controlled trial of recombinant human growth hormone. BMC Pediatr. 2011 May 29;11:49. doi: 10.1186/1471-2431-11-49.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	0.05 mg/kg	Subcutaneous
Background	ethinyl estradiol	Small molecule	20 ug	—
Background	medroxyprogesterone acetate	Other / unclassified	10 mg	—

Indications