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

Primary Purpose

Osteoporosis, Growth Hormone Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
growth hormone
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring disease-related problem/condition, endocrine disorders, growth hormone deficiency, osteoporosis, quality of life, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Mayo Clinic
  • St. Louis University Health Sciences Center
  • Case Western Reserve University
  • Oregon Health Sciences University
  • University of Pennsylvania School of Medicine
  • Rhode Island Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 4, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00006394
Brief Title
Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Pennsylvania

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Growth Hormone Deficiency
Keywords
disease-related problem/condition, endocrine disorders, growth hormone deficiency, osteoporosis, quality of life, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double
Allocation
Randomized
Enrollment
72 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
growth hormone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Snyder
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2617
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-0250
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

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

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