Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature - Full Text View

Sponsors and Collaborators:	Rabin Medical Center Pfizer
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00458263

Purpose

One arm, open, prospective, intervention study to assess biochemical markers of growth response to GH treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with GH during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years. The impact of GH therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period. Samples will be test for biochemical markers of bone formation and resorption: bone alkaline phosphatase, osteocalcin, type I procollagen propeptide (PICP), hydroxyproline, pyridinoline, deoxypyridinoline, ICTP, TRAcP, GHL, NTX-I, BSP. The primary endpoints are measurements of height and growth velocity during the year of GH treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires. Safety parameters are IGF1 and HbA1c, measured at baseline, 3 month and than every 6 months

Condition	Intervention	Phase
Idiopathic Short Stature	Drug: Somatotropin growth hormone recombinant human	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	One Arm, Open Study to Assess Biochemical Markers of Growth Response to GH Treatment in Children With Idiopathic Short Stature

Resource links provided by NLM:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Height [ Time Frame: every 4 months ] [ Designated as safety issue: No ]
Growth velocity [ Time Frame: every 4 months ] [ Designated as safety issue: No ]
Height at beginning of puberty [ Time Frame: At the biginning of puberty ] [ Designated as safety issue: No ]
Final height [ Time Frame: When acheiving final height ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychological parameters [ Time Frame: once a year ] [ Designated as safety issue: No ]
HbA1c and IGF-1 [ Time Frame: at baseline. after 3 months and than every 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	April 2006
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental	Drug: Somatotropin growth hormone recombinant human daily SC injections

Detailed Description:

One arm, open prospective intervention study to assess biochemical markers of growth response to GH treatment in 20 children, aged 3-9 years old, with idiopathic short stature.

Objectives:

To determine axiological and biochemical markers for growth response
To assess the period of time necessary to determine the parameters which will differentiate between responders and non-responders

Inclusion criteria:

Ages 3 to <9 years
Short stature with height >2.25 SD below the mean
Prepubertal (Tanner stage I) at commencement of trial
Peak GH above 10ng/ml in at least one provocative test for GH secretion
Signing Informed consent forms

Exclusion criteria:

IUGR
Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
Diabetes
Treatment with any medical product which may interfere with GH effects

Methods:

All participants will be treated with GH during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years.
The impact of GH therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period.Samples will be test for biochemical markers of bone formation and resorption: bone alkaline phosphatase, osteocalcin, type I procollagen propeptide (PICP), hydroxyproline, pyridinoline, deoxypyridinoline, ICTP, TRAcP, GHL, NTX-I, BSP.
The primary endpoints are measurements of height and growth velocity during the year of GH treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.
Safety parameters are IGF1 and HbA1c, measured at baseline, 3 month and than every 6 months

Eligibility

Ages Eligible for Study:	3 Years to 9 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 3 to <9 years
Short stature with height >2.25 SD below the mean
Prepubertal (Tanner stage I) at commencement of trial
Peak GH above 10ng/ml in at least one provocative test for GH secretion
Signing informed consent forms

Exclusion Criteria:

IUGR
Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
Diabetes
Treatment with any medical product which may interfere with GH

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458263

Contacts

Contact: Moshe Phillip, Prof, MD

972-3-9253778

mosheph@clalit.org.il

Locations

Israel
schneider children medical center of Israel	Recruiting
Petach Tikva, Israel, 49202
Sub-Investigator: liora Lazar, Dr, MD
Sub-Investigator: Shlomit Shalitin, Dr, MD
Sub-Investigator: Revital Nimri, Dr, MD
Sub-Investigator: Liat de Vries, Dr, MD
Sub-Investigator: Yael Lebenthal, Dr, MD
Sub-Investigator: Ariel Tenenbaum, Dr, MD
Sub-Investigator: Neomi Weintrob, Dr, MD

Sponsors and Collaborators

Rabin Medical Center

Pfizer

Investigators

Principal Investigator:

Moshe Phillip, Prof, MD

Schneider Children Medical Center

More Information

No publications provided

Responsible Party:	Rabin Medical Center ( Prof. Moshe Phillip )
Study ID Numbers:	rmc003515ctil
Study First Received:	April 8, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00458263 History of Changes
Health Authority:	Israel: Clalit Health services

Keywords provided by Rabin Medical Center:

GH treatment
ISS
Biochemical markers
Growth response

Study placed in the following topic categories:

Hormones

ClinicalTrials.gov processed this record on July 02, 2009