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

Not Applicable

Withdrawn

• Conditions: Short Stature
• Interventions: Drug: Growth Hormone

• Registration Number: NCT01970800
• Lead Sponsor: Maimonides Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-10-23
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-10-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Growth hormone, injections	Growth Hormone	Growth hormone injection 0.3mg/kg/week dailY

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Outcome measurement	one year	Growth velocity after treatment with appropriate growth hormone doses

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States