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

Genentech

Status: Completed

Conditions: Turner Syndrome; Dwarfism, Pituitary

Study type: Observational

Funder types: Industry

Identifiers

NCT00097526

85-036, Substudy 10

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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.)