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

Maimonides Medical Center

Status: Withdrawn

Conditions: Short Stature

Treatments: Drug: Growth Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT01970800

10/01/VA03

Details and patient eligibility

About

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.

Sex: All

Ages: 5 to 11 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Growth hormone, injections

Experimental group

Description:

Growth hormone injection 0.3mg/kg/week dailY

Treatment:

Drug: Growth Hormone