- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01970800
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature
August 15, 2018 updated by: Maimonides Medical Center
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.
Study Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11219
- Maimonides Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 11 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Growth hormone, injections
Growth hormone injection 0.3mg/kg/week dailY
|
Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Efficacy Outcome measurement
Time Frame: one year
|
Growth velocity after treatment with appropriate growth hormone doses
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Svetlana Ten, MD, Maimonides Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2013
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
October 23, 2013
First Submitted That Met QC Criteria
October 25, 2013
First Posted (ESTIMATE)
October 28, 2013
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2018
Last Update Submitted That Met QC Criteria
August 15, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/01/VA03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Short Stature
-
Xiaoping LuoRecruitingChildhood Short StatureChina
-
Belgian Study Group for Pediatric EndocrinologyActive, not recruitingIdiopathic Short StatureBelgium
-
Dong-A ST Co., Ltd.CompletedIdiopathic Short Stature
-
Merck KGaA, Darmstadt, GermanyCompletedIdiopathic Short StatureKorea, Republic of
-
PfizerCompletedIdiopathic Short StatureUnited States
-
Rabin Medical CenterPfizerCompleted
-
BioMarin PharmaceuticalNot yet recruitingIdiopathic Short Stature
-
Novo Nordisk A/SRecruitingIdiopathic Short StatureUnited States
-
University of Erlangen-Nürnberg Medical SchoolCompletedIdiopathic Short StatureGermany
-
Children's Hospital Medical Center, CincinnatiCompleted
Clinical Trials on Growth Hormone
-
The University of Texas Medical Branch, GalvestonCompletedMild Cognitive ImpairmentUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)TerminatedAging | Hormone DeficiencyUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of WashingtonNational Institute on Aging (NIA)CompletedAging | Mild Cognitive ImpairmentUnited States
-
Massachusetts General HospitalCompleted
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealthy VolunteersUnited States
-
University of PennsylvaniaCompletedCongestive Heart FailureUnited States
-
Versartis Inc.Completed
-
Rabin Medical CenterPfizerCompleted
-
Massachusetts General HospitalActive, not recruitingObesity | Fatty Liver | Liver Fat | Obesity, Abdominal | Non-Alcoholic Fatty Liver DiseaseUnited States