Not Signed In -
Pituitary Gland Diseases And Disorders |
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Clinical Trial: Bone Mineral Density (BMD) in Adolescents with Growth Hormone Deficiency (GHD)
This study is currently recruiting patients.
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Purpose
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 growth hormone (GH) treatment for statural indications.
| Condition | Phase |
|---|---|
| Dwarfism, Pituitary Turner Syndrome | Phase IV |
MedlinePlus related topics: Bone Diseases; Dwarfism; Pituitary Disorders; Turner's Syndrome
Genetics Home Reference related topics: Turner syndrome
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
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)
Study start: April 2000; Expected completion: December 2099
Last follow-up: December 2099; Data entry closure: December 2099
Eligibility
Ages Eligible for Study: up to 17 Years, Genders Eligible for Study: Both
Criteria
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.)
Location and Contact Information
California
Genentech Central Contact, South San Francisco, California, 94080, United States; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 3, 2005
Record first received: November 24, 2004
ClinicalTrials.gov Identifier: NCT00097526
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Acromegaly (National Institute of Diabetes and Digestive and Kidney Diseases)
- Cushing's Syndrome (National Institute of Diabetes and Digestive and Kidney Diseases)
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