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

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.

Completed

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Bone Diseases, Metabolic Brain Diseases Central Nervous System Diseases Disease Attributes Dwarfism Dwarfism, Pituitary Endocrine System Diseases Growth Hormone Deficiency Hypopituitarism Hypothalamic Diseases Metabolic Diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pituitary Diseases Rare Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

growth hormone

Drug

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

University of Pennsylvania

Registry information

Important dates

Study start: 1997
First posted: Oct 5, 2000
Registry last updated: Jun 24, 2005

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