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Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004815
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

OBJECTIVES:

I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werner's syndrome and osteoporosis.


Condition Intervention
Werner's Syndrome Drug: growth hormone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 1
Study Start Date: May 1992
Detailed Description:

PROTOCOL OUTLINE: The patient receives subcutaneous recombinant human insulin-like growth factor 1 daily for 7 months. The dose is adjusted according to the serum hormone level and biological markers of bone turnover.

Concurrent therapy includes a metabolic diet, calcium citrate, and estradiol.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Werner's syndrome with osteoporosis and low serum insulin-like growth factor 1 level Patient treated on protocol 04-9215300 "Metabolic and Skeletal Effects of Exogenous Recombinant Human Insulin-Like Growth Factor"

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004815


Sponsors and Collaborators
National Center for Research Resources (NCRR)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Texas
Investigators
Study Chair: Craig D. Rubin University of Texas
  More Information

ClinicalTrials.gov Identifier: NCT00004815     History of Changes
Other Study ID Numbers: 199/12024
UTSMC-49215300
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: December 9, 2005
Last Verified: July 2004

Keywords provided by Office of Rare Diseases (ORD):
Werner's syndrome
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Syndrome
Werner Syndrome
Disease
Pathologic Processes
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs