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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00097526
First Posted: November 25, 2004
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  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 GH treatment for statural indications.

Condition Phase
Dwarfism, Pituitary Turner Syndrome Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Enrollment: 125
Study Start Date: April 2000
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic
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.)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097526


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Barbara Lippe, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097526     History of Changes
Other Study ID Numbers: 85-036, Substudy 10
First Submitted: November 24, 2004
First Posted: November 25, 2004
Last Update Posted: November 14, 2012
Last Verified: November 2012

Keywords provided by Genentech, Inc.:
Growth Hormone Deficiency

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Ovarian Diseases
Adnexal Diseases