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

This study is currently recruiting participants.

Verified by Genentech, July 2008

First Received: November 24, 2004 Last Updated: July 14, 2008 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097526

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 IV

Study Type:	Observational
Study Design:	Cohort, 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:

Genetics Home Reference related topics: pseudoachondroplasia Turner syndrome

MedlinePlus related topics: Dwarfism Minerals Turner Syndrome

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Genentech:

Biospecimen Retention: None Retained

Biospecimen Description:

Study Start Date:	April 2000
Estimated Study Completion Date:	December 2099

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

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

Contacts

Contact: Trial Information Support Line

800-723-6247

Locations

United States, California
Trial Information Support Line	Recruiting
South San Francisco, California, United States, 94080
Contact 800-723-6247

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Barbara Lippe, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	85-036, Substudy 10
Study First Received:	November 24, 2004
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00097526 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

Growth Hormone Deficiency

Additional relevant MeSH terms:

Dwarfism, Pituitary
Pituitary Diseases
Bone Diseases, Endocrine
Dwarfism
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Brain Diseases
Hormones
Bone Diseases
Sex Differentiation Disorders
Pathologic Processes
Urogenital Abnormalities
Hypopituitarism
Musculoskeletal Diseases

Syndrome
Bone Diseases, Developmental
Congenital Abnormalities
Hypothalamic Diseases
Disease
Nervous System Diseases
Chromosome Disorders
Endocrine System Diseases
Central Nervous System Diseases
Pharmacologic Actions
Turner Syndrome
Genetic Diseases, Inborn
Sex Chromosome Disorders
Gonadal Dysgenesis

ClinicalTrials.gov processed this record on November 20, 2009