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

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

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

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097526

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

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00097526     History of Changes
Other Study ID Numbers: 85-036, Substudy 10
Study First Received: November 24, 2004
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
Growth Hormone Deficiency

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
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
Gonadal Disorders
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on July 29, 2014