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The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

Sponsor
Maimonides Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT01970800
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
23
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.

Condition or Disease Intervention/Treatment Phase
  • Drug: Growth Hormone
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This study was changed to a retrospective chart review. There was no prospective component.This study was changed to a retrospective chart review. There was no prospective component.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
Actual Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Growth hormone, injections

Growth hormone injection 0.3mg/kg/week dailY

Drug: Growth Hormone
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
Other Names:
  • Nutropin AQ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Primary Efficacy Outcome measurement [one year]

      Growth velocity after treatment with appropriate growth hormone doses

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • ability to provide written informed consent

    • Prepubertal males and females form 5- 11years old

    • Bone age <11 years in males and <9 years in females

    • Height SD score<-2.25SD in males and females

    • IGF-1SD score <-1SD in both males and females

    • Peak GH level after stimulation >10ng/ml

    Exclusion Criteria:

    • History of prior chemotherapy and or radiation

    • Active neoplasm

    • Pediatric patients with closed epiphyses

    • Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly

    • Treatment with inhaled or systemic steroids

    • BMI <5th percentile or >95th percentile

    • Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Maimonides Medical Center Brooklyn New York United States 11219

    Sponsors and Collaborators

    • Maimonides Medical Center

    Investigators

    • Principal Investigator: Svetlana Ten, MD, Maimonides Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maimonides Medical Center
    ClinicalTrials.gov Identifier:
    NCT01970800
    Other Study ID Numbers:
    • 10/01/VA03
    First Posted:
    Oct 28, 2013
    Last Update Posted:
    Aug 17, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Maimonides Medical Center
    IGF-1
    Short Stature
    GH
    Additional relevant MeSH terms:
    Dwarfism
    Hormones

    Study Results

    No Results Posted as of Aug 17, 2018