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

This study has been completed.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006394
First received: October 4, 2000
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

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.


Condition Intervention
Osteoporosis
Growth Hormone Deficiency
Drug: growth hormone

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 72
Study Start Date: April 1997
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006394

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2617
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
University of Pennsylvania
Investigators
Study Chair: Peter Snyder University of Pennsylvania
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006394     History of Changes
Other Study ID Numbers: 199/15433, UPSM-209300, LILLY-B9R-US-GDEO
Study First Received: October 4, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
disease-related problem/condition
endocrine disorders
growth hormone deficiency
osteoporosis
quality of life
rare disease

Additional relevant MeSH terms:
Dwarfism, Pituitary
Osteoporosis
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Bone Diseases, Metabolic
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014