NCT00004815

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1992

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2004

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Werner's Syndrome

Keywords

Werner's syndromegenetic diseases and dysmorphic syndromesrare disease

Interventions

growth hormoneDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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"

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Werner SyndromeGenetic Diseases, InbornRare Diseases

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Craig D. Rubin

    University of Texas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

May 1, 1992

Last Updated

June 24, 2005

Record last verified: 2004-07