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

Overview

OBJECTIVES: I. Assess the safety and efficacy of recombinant human insulin-like growth factor 1 in a patient with Werner's syndrome and osteoporosis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Primary Purpose: Treatment

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.

Interventions

  • Drug: growth hormone

Participating in This Clinical Trial

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"

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Center for Research Resources (NCRR)
  • Collaborator
    • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Overall Official(s)
    • Craig D. Rubin, Study Chair, University of Texas

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