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Trial record 1 of 1 for:    WERNER SYNDROME
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Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome

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ClinicalTrials.gov Identifier: NCT00004815
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Information provided by:

Study Description
Brief Summary:


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
Werner's Syndrome Drug: growth hormone

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

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


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

ClinicalTrials.gov Identifier: NCT00004815     History of Changes
Other Study ID Numbers: 199/12024
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:
Werner Syndrome
Pathologic Processes
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs