Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.

July 13, 2010 updated by: Rabin Medical Center

Two Arms, Open, Controlled, Prospective, Intervention Study to Evaluate the Growth and Metabolic Response to Growth Hormone and Gonadotropin-releasing Hormone Agonist Treatment Versus Growth Hormone Alone in Boys Born SGA

A 2-arms randomized open prospective intervention study to determine the Growth and metabolic response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth hormone alone in boys born SGA.

All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d.

At onset of puberty, subjects will be randomized into either combined treatment with GH and GnRHa or GH alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 2-arms randomized open prospective intervention study including 20 boys, in order to determine the effect of growth hormone (GH) and gonadotropin-releasing hormone agonist treatment versus growth hormone (GnRHa) alone on growth and metabolic response.

Objectives:

The primary objective is to investigate the effect of delaying the pubertal process by pubertal suppression on growth and final height of boys who were born SGA and treated with GH.

The secondary objectives are to determine the metabolic effect of the combined therapy of GH plus gonadotropin agonists to that of GH alone on the dietary intake, serum leptin, ghrelin, IGF-1, lipid and lipoprotein concentrations prior to and during treatment, and to assess the quality of life between the two groups.

Study population:

20 prepubertal boys.

Inclusion Criteria:

  1. Ages 10-13
  2. IUGR
  3. Height of at least 2 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC).
  4. prepubertal(Tanner stage 1) at commencement of trail.
  5. Peak GH above 10ng/ml in at least one provocative test for GH secretion.
  6. Signed informed consent form.

Exclusion criteria:

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

Trail design:

A prospective, randomized controlled study assessing the impact of two years of combined treatment with GH and GnRHa on height of boys with severe growth failure due to SGA with height >2.25 SDS , compared with GH alone.

All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d. At onset of puberty (testicular volume greater than 4 ml in consecutive examinations) subjects will be randomized into either combined treatment with GH and GnRHa or GH alone.

Methods:

  1. Urine test will be held every three months.
  2. X-ray photograph for bone age determination will be taken at baseline and every year after.
  3. Blood will be taken at baseline and every year after in order to evaluate the following parameters: Lipid and lipoprotein concentrations, ghrelin, leptin, glucose, insulin and HbA1c.
  4. Blood will be taken on randomization visit and three months after in order to evaluated the following parameters: LH, FSH and Testosterone
  5. Blood will be taken at baseline and every half a year after to evaluate levels of IGF-1.
  6. For evaluation of the growth hormone response, additional blood tests will be preformed one month and three months after treatment with growth hormone.
  7. On every blood and urine that will be taken, proteomic analysis will be held.
  8. Before treatment with growth hormone, one year after treatment and in the end of the study quality of life questionnaire, appetite questionnaire and Psychological questionnaires will be filled.

The safety of growth hormone treatment will be assessed from:

  1. Monitoring of adverse events.
  2. Measurement of HbA1c.
  3. Measurement of hematology, serum biochemistry and urinalysis laboratory variables.
  4. Measurement of fasting glucose and insulin concentrations.
  5. IGF-1
  6. Physical examinations and measurements of vital signs height and body weight.
  7. Measurement of bone age.

Study Type

Interventional

Enrollment (Actual)

17

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

  • Israel
      • Petach-Tikva, Israel
        • Schnider children 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

9 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Boys
  2. IUGR
  3. Ages 10-13
  4. height of at list 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC)
  5. Prepubertal (tanner stage 1) at commencement of trail
  6. Peak GH above 10ng/ml in at least one provocative test for GH secretion 7.Signed informed consent

Exclusion Criteria:

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
GH & GNRHa treatment
Drug: growth hormone and gonadotropin-releasing hormone agonist
GH & GNRHa treatment
Active Comparator: 2
GH treatment
Drug: growth hormone
GH treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Height measurements
Time Frame: every 3 monthes, during all study period
every 3 monthes, during all study period

Secondary Outcome Measures

Outcome Measure
Time Frame
IGF-1 concentration
Time Frame: every 6 monthes, during all study period
every 6 monthes, during all study period
Hormone profile, Lipid and lipoprotein concentrations
Time Frame: once a year during all study period
once a year during all study period
Prepubertal changes
Time Frame: every 3 monthes during all study peiod
every 3 monthes during all study peiod
Bone age
Time Frame: once a year, during all study period
once a year, during all study period
quality of life questionnaire
Time Frame: once a year, during all study period
once a year, during all study period
Psychological questionnaire
Time Frame: once a year, during all study peiod
once a year, during all study peiod

Collaborators and Investigators

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

Sponsor

Rabin Medical Center

Collaborators

Pfizer

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

May 1, 2005

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

July 14, 2010

Last Update Submitted That Met QC Criteria

July 13, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc073243ctil
  • SGA boys 3243

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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