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

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.
 
ClinicalTrials.gov Identifier: NCT00004815
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Texas
Information provided by:
Office of Rare Diseases (ORD)

Brief Summary:

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 or disease Intervention/treatment Phase
Werner's Syndrome Drug: growth hormone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Study Start Date : May 1992

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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"


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
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Study Chair: Craig D. Rubin University of Texas
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ClinicalTrials.gov Identifier: NCT00004815    
Other Study ID Numbers: 199/12024
UTSMC-49215300
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 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:
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Werner Syndrome
Syndrome
Disease
Pathologic Processes
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs