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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01970800
First Posted: October 28, 2013
Last Update Posted: October 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Maimonides Medical Center
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970800


Contacts
Contact: Svetlana Ten, MD 718-283-8894 tenlana@aol.com

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

Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01970800     History of Changes
Other Study ID Numbers: 10/01/VA03
First Submitted: October 23, 2013
First Posted: October 28, 2013
Last Update Posted: October 28, 2013
Last Verified: October 2013

Keywords provided by Maimonides Medical Center:
IGF-1
Short Stature
GH

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs