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

Short Stature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01970800
• Other study ID #: 10/01/VA03
• Status: Withdrawn
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2018
• Source: Maimonides Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Dwarfism
• Short Stature

Intervention

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

Locations

Country	Name	City	State
United States	Maimonides Medical Center	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Outcome measurement	Growth velocity after treatment with appropriate growth hormone doses	one year