Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

NCT ID: NCT00006394

Last Updated: 2005-06-24

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-04-30

Brief Summary

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OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo.

II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH.

III. Compare the quality of life of these patients treated with these 2 regimens.

IV. Determine the side effects of GH in these patients.

Detailed Description

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PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive growth hormone subcutaneously (SC) daily for 2 years. Arm II: Patients receive placebo SC daily for 2 years. Quality of life is assessed at the initial eligibility screening, then again within 1 month after the initial screening, and then at 1, 3, and 6 months during study therapy.

Conditions

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Osteoporosis Growth Hormone Deficiency

Keywords

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disease-related problem/condition endocrine disorders growth hormone deficiency osteoporosis quality of life rare disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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growth hormone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of adult onset growth hormone deficiency

--Patient Characteristics--

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Peter Snyder

Role: STUDY_CHAIR

University of Pennsylvania

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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UPSM-209300

Identifier Type: -

Identifier Source: secondary_id

LILLY-B9R-US-GDEO

Identifier Type: -

Identifier Source: secondary_id

199/15433

Identifier Type: -

Identifier Source: org_study_id