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

NCT01970800 | Withdrawn DMC

• 1 other identifier: 10/01/VA03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Stature

Keywords

IGF-1; Short Stature; GH

Outcome Measures

Primary Outcomes (1)

• Primary Efficacy Outcome measurement

  Growth velocity after treatment with appropriate growth hormone doses

  one year

Study Arms (1)

Growth hormone, injections

EXPERIMENTAL

Growth hormone injection 0.3mg/kg/week dailY

Drug: Growth Hormone

Interventions

Growth Hormone DRUG

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

Also known as: Nutropin AQ

Growth hormone, injections

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Dwarfism

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Svetlana Ten, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study was changed to a retrospective chart review. There was no prospective component.

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (1)