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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Maimonides Medical Center
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01970800
First received: October 23, 2013
Last updated: October 25, 2013
Last verified: October 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01970800     History of Changes
Other Study ID Numbers: 10/01/VA03
Study First Received: October 23, 2013
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014