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

Lilly

Status and phase: Completed; Phase 4

Conditions: Turner Syndrome

Treatments: Drug: Humatrope

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266656

B9R-US-GDGH (Other Identifier)

10088

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: Female

Ages: 4 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Previously randomized in study B9R-US-GDFG (NCT00406926)
• Karyotype-proven Turner syndrome

Exclusion criteria

• Immediate family members of study site personnel directly affiliated with the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

Experimental 1 Control

Experimental group

Description:

No drug administration in B9R-US-GDFG (NCT00406926). Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.

Treatment:

Drug: Humatrope

Experimental 2 Humatrope

Experimental group

Description:

Humatrope according to investigator's clinical practice and guided by the approved package insert on whether treatment is given.

Treatment:

Drug: Humatrope