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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT00097526
First received: November 24, 2004
Last updated: November 13, 2012
Last verified: November 2012

November 24, 2004
November 13, 2012
April 2000
July 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00097526 on ClinicalTrials.gov Archive Site
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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)

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

primary care clinic

  • Dwarfism, Pituitary
  • Turner Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
July 2010
July 2010   (final data collection date for primary outcome measure)

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.)
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00097526
85-036, Substudy 10
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Genentech, Inc.
Genentech, Inc.
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Study Director: Barbara Lippe, M.D. Genentech, Inc.
Genentech, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP