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

Bone Mineral Density in Adolescent Subjects With Growth Hormone Deficiency Who Are Completing Treatment With Nutropin AQ, Nutropin, or Protropin in the National Cooperative Growth Study (NCGS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00097526

Enrollment

125

Registered

2004-11-25

Start date

2000-04-30

Completion date

2010-07-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dwarfism, Pituitary, Turner Syndrome

Keywords

Growth Hormone Deficiency

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

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.)

Outcome results