Turner Syndrome Clinical Trial
Official title:
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)
Verified date | November 2012 |
Source | Genentech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 17 Years |
Eligibility |
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.) |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Genentech, Inc. |
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