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

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.
 
ClinicalTrials.gov Identifier: NCT00097526
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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 GH treatment for statural indications.

Condition or disease
Dwarfism, Pituitary Turner Syndrome

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Study Type : Observational
Actual Enrollment : 125 participants
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)
Study Start Date : April 2000
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010






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.)

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
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Study Director: Barbara Lippe, M.D. Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097526    
Other Study ID Numbers: 85-036, Substudy 10
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012
Keywords provided by Genentech, Inc.:
Growth Hormone Deficiency
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Dwarfism
Turner Syndrome
Gonadal Dysgenesis
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
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