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

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Texas
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004815
  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

Genetics Home Reference related topics:   Werner syndrome   

MedlinePlus related topics:   Osteoporosis   

Drug Information available for:   Insulin    Somatotropin    Somatropin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized

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
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004815

Sponsors and Collaborators

Investigators
Study Chair:     Craig D. Rubin     University of Texas    
  More Information


Study ID Numbers:   199/12024, UTSMC-49215300
First Received:   February 24, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004815
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Metabolic Diseases
Genetic Diseases, Inborn
Rare Diseases
Osteoporosis
Werner's syndrome
Metabolic disorder
Werner Syndrome
Insulin

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on November 20, 2008




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