NCT00006394

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

October 4, 2000

Last Update Submit

June 23, 2005

Conditions

OsteoporosisGrowth Hormone Deficiency

Keywords

disease-related problem/conditionendocrine disordersgrowth hormone deficiencyosteoporosisquality of liferare disease

Interventions

growth hormoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Massachusetts General Hospital

Boston, Massachusetts, 02114-2617, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

St. Louis University Health Sciences Center

St Louis, Missouri, 63110-0250, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201-3098, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

OsteoporosisDwarfism, PituitaryEndocrine System DiseasesRare Diseases

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesDwarfismBone Diseases, DevelopmentalBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Peter Snyder

    University of Pennsylvania

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 4, 2000

First Posted

October 5, 2000

Study Start

April 1, 1997

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(7)