Status:
COMPLETED
Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD)
Lead Sponsor:
Genentech, Inc.
Conditions:
Dwarfism, Pituitary
Turner Syndrome
Eligibility:
All Genders
Up to 17 years
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 G...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
April 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00097526
Start Date
April 1 2000
End Date
July 1 2010
Last Update
November 14 2012
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