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NCT00097526 Clinical Trial

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

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00097526
Other study ID # 85-036, Substudy 10
Secondary ID
Status Completed
Phase Phase 4
First received November 24, 2004
Last updated November 13, 2012
Start date April 2000
Est. completion date July 2010

Study information
Verified date November 2012
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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.)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.
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