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

NCT ID: NCT01970800

Last Updated: 2018-08-17

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Short Stature

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This study was changed to a retrospective chart review. There was no prospective component.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Growth hormone, injections

Growth hormone injection 0.3mg/kg/week dailY

Group Type EXPERIMENTAL

Growth Hormone

Intervention Type DRUG

Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months

Interventions

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Growth Hormone

Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months

Intervention Type DRUG

Other Intervention Names

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Nutropin AQ

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maimonides Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Svetlana Ten, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

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Maimonides Medical Center

Brooklyn, New York, United States

Site Status

Countries

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United States

Other Identifiers

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10/01/VA03

Identifier Type: -

Identifier Source: org_study_id

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