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

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004815
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: July 2004
  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

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

No publications provided

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

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

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

ClinicalTrials.gov processed this record on April 20, 2014