Clinical Trials Directory

Trials / Completed

CompletedNCT00266656

Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome

Effect of Early Growth Hormone Treatment on Long-term Growth and Skeletal Maturation in Girls With Turner Syndrome

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
69 (actual)
Sponsor
Eli Lilly and Company · Industry
Sex
Female
Age
4 Years – 20 Years
Healthy volunteers
Not accepted

Summary

This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.

Conditions

Interventions

TypeNameDescription
DRUGHumatropeAccording to investigator's clinical practice and guided by the approved package insert

Timeline

Start date
2005-12-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2005-12-19
Last updated
2017-03-31
Results posted
2016-08-23

Locations

9 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00266656. Inclusion in this directory is not an endorsement.