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

Primary Purpose

Werner's Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
growth hormone
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Werner's Syndrome focused on measuring Werner's syndrome, genetic diseases and dysmorphic syndromes, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), University of Texas
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004815
    Brief Title
    Descriptive Study of Recombinant Human Insulin-Like Growth Factor for Osteoporosis in Werner's Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1992 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Werner's Syndrome
    Keywords
    Werner's syndrome, genetic diseases and dysmorphic syndromes, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Allocation
    Non-Randomized
    Enrollment
    1 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    growth hormone

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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"
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Craig D. Rubin
    Organizational Affiliation
    University of Texas
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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