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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Werner syndrome

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

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

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

No publications provided

Study ID Numbers:	199/12024, UTSMC-49215300
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004815 History of Changes
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
Mitogens
Osteoporosis

Werner Syndrome
Hormones
Metabolic Disorder
Insulin
Werner's Syndrome

Additional relevant MeSH terms:

Metabolic Diseases
Pathologic Processes
Disease
Genetic Diseases, Inborn

Syndrome
DNA Repair-Deficiency Disorders
Werner Syndrome

ClinicalTrials.gov processed this record on July 02, 2009