Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature (ISS)

January 1, 2013 updated by: Rabin Medical Center

One Arm, Open Study to Assess Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

One arm, open, prospective, intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with Growth Hormone 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 Growth Hormone 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. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Objectives:

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

Inclusion criteria:

  1. Ages 3 to <9 years
  2. Short stature with height >2.25 Standard Deviation below the mean
  3. Prepubertal (Tanner stage I) at commencement of trial
  4. Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
  5. Signing Informed consent forms

Exclusion criteria:

  1. Intra Uterine Growth Retardation
  2. Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
  3. Diabetes
  4. Treatment with any medical product which may interfere with Growth Hormone effects

Methods:

  1. All participants will be treated with Growth Hormone 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.
  2. The impact of Growth Hormone 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
  3. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

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

  • Israel
      • Petach Tikva, Israel, 49202
        • Schneider Children Medical Center of Israel

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

3 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Intra Uterine Growth Retardation
  • Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
  • Diabetes
  • Treatment with any medical product which may interfere with Growth Hormone

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
Drug: Somatotropin growth hormone recombinant human
daily Sub Cutaneous injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Height
Time Frame: every 4 months
every 4 months
Growth velocity
Time Frame: every 4 months
every 4 months
Height at beginning of puberty
Time Frame: At the biginning of puberty
At the biginning of puberty
Final height
Time Frame: When acheiving final height
When acheiving final height

Secondary Outcome Measures

Outcome Measure
Time Frame
Psychological parameters
Time Frame: once a year
once a year
HbA1c and IGF-1
Time Frame: at baseline. after 3 months and than every 6 months
at baseline. after 3 months and than every 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Collaborators

Pfizer

Investigators

  • Principal Investigator: Moshe Phillip, Prof, MD, Schneider Children 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

April 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 8, 2007

First Submitted That Met QC Criteria

April 8, 2007

First Posted (Estimate)

April 10, 2007

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 1, 2013

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc003515ctil

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.

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