This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Maimonides Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Maimonides Medical Center Identifier:
First received: October 23, 2013
Last updated: October 25, 2013
Last verified: October 2013
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.

Condition Intervention Phase
Short Stature Drug: Growth Hormone Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

Resource links provided by NLM:

Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Primary Efficacy Outcome measurement [ Time Frame: one year ]
    Growth velocity after treatment with appropriate growth hormone doses

Estimated Enrollment: 35
Study Start Date: January 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Growth hormone, injections
Growth hormone injection 0.3mg/kg/week dailY
Drug: Growth Hormone
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
Other Name: Nutropin AQ


Ages Eligible for Study:   5 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01970800

Contact: Svetlana Ten, MD 718-283-8894

United States, New York
Maimonides Medical Center Not yet recruiting
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
Principal Investigator: Svetlana Ten, MD Maimonides Medical Center
  More Information

Responsible Party: Maimonides Medical Center Identifier: NCT01970800     History of Changes
Other Study ID Numbers: 10/01/VA03
Study First Received: October 23, 2013
Last Updated: October 25, 2013

Keywords provided by Maimonides Medical Center:
Short Stature

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017