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

August 15, 2018 updated by: Maimonides Medical Center
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Growth hormone, injections
Growth hormone injection 0.3mg/kg/week dailY
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
Other Names:
  • Nutropin AQ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Outcome measurement
Time Frame: one year
Growth velocity after treatment with appropriate growth hormone doses
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 25, 2013

First Posted (ESTIMATE)

October 28, 2013

Study Record Updates

Last Update Posted (ACTUAL)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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