Back to resultsThe Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
Primary Purpose
Short Stature
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Growth Hormone
Sponsored by
About this trial
This is an interventional other trial for Short Stature focused on measuring IGF-1, Short Stature, GH
Eligibility 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
Sites / Locations
- Maimonides Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Growth hormone, injections
Arm Description
Growth hormone injection 0.3mg/kg/week dailY
Outcomes
Primary Outcome Measures
Primary Efficacy Outcome measurement
Growth velocity after treatment with appropriate growth hormone doses
Secondary Outcome Measures
Full Information
NCT ID
NCT01970800
First Posted
October 23, 2013
Last Updated
August 15, 2018
Sponsor
Maimonides Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01970800
Brief Title
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
Official Title
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Nature of study was changed from ACT to retrospective chart review
Study Start Date
January 2013 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimonides Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature
Keywords
IGF-1, Short Stature, GH
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study was changed to a retrospective chart review. There was no prospective component.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Growth hormone, injections
Arm Type
Experimental
Arm Description
Growth hormone injection 0.3mg/kg/week dailY
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
Nutropin AQ
Intervention Description
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
Primary Outcome Measure Information:
Title
Primary Efficacy Outcome measurement
Description
Growth velocity after treatment with appropriate growth hormone doses
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svetlana Ten, MD
Organizational Affiliation
Maimonides Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
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