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

Werner's Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004815
• Other study ID #: 199/12024
• Secondary ID: UTSMC-49215300
• Status: Completed
• Phase: N/A
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: May 1992

Study information

• Verified date: July 2004
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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"

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Syndrome
• Werner Syndrome
• Werner's Syndrome

Intervention

Drug:
• growth hormone

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Texas