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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-04-30

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dwarfism, Pituitary Turner Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Growth Hormone Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara Lippe, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

85-036, Substudy 10

Identifier Type: -

Identifier Source: org_study_id