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

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.

Completed

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Key information

Conditions

Dwarfism, Pituitary Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disorders of Sex Development Dwarfism Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Gonadal Disorders Gonadal Dysgenesis Heart Defects, Congenital Heart Diseases Hypopituitarism Hypothalamic Diseases Male Urogenital Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Turner Syndrome Urogenital Abnormalities Urogenital Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start: 2000
Primary completion: 2010
Study completion: 2010
First posted: Nov 25, 2004
Registry last updated: Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed