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

N/AWithdrawnNCT01970800

Maimonides Medical Center

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Short Stature

Interventions

Growth HormoneDRUG

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maimonides Medical Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

Primary Efficacy Outcome measurement

Growth velocity after treatment with appropriate growth hormone doses

Time frame: one year

Data from ClinicalTrials.gov

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