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

NCT ID: NCT00004815

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

1992-05-31

Brief Summary

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OBJECTIVES:

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

Detailed Description

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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.

Conditions

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Werner's Syndrome

Keywords

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Werner's syndrome genetic diseases and dysmorphic syndromes rare disease

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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growth hormone

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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"
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

University of Texas

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Craig D. Rubin

Role: STUDY_CHAIR

University of Texas

Other Identifiers

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UTSMC-49215300

Identifier Type: -

Identifier Source: secondary_id

199/12024

Identifier Type: -

Identifier Source: org_study_id