Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD)

Completed

• Conditions: Dwarfism, Pituitary; Turner Syndrome

• Registration Number: NCT00097526
• Lead Sponsor: Genentech, Inc.

Brief Summary

This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing GH treatment for statural indications.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04
• Study First Submitted: 2004-11-24
• Study First Submitted QC: 2004-11-24
• Study First Posted: 2004-11-25
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Bone age of at least 15 years for girls or at least 16 years for boys within 6 months of obtaining the DXA scan
• Previous enrollment in the NCGS core study, 85-036
• Tanner Stage 4 or greater
• Either spontaneous or induced puberty
• Subjects who plan on terminating GH treatment for statural purposes for one or more of the following reasons: epiphyseal fusion, slowing growth rate indicates that near adult height has been reached, or satisfied with current height

Exclusion Criteria

• Current therapy with a non Genentech GH product
• Pregnancy (to avoid exposure to low levels of radiation from DXA scanners)
• Bilateral hip replacement
• Weight >130 kg (286 lb.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified