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

NCT00522743

Last updated date
Study Location
Schnider children medical center
Petach-Tikva, , , Israel
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
SGA and Growth
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
9-13 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

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SGA and GrowthGrowth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.
NCT00522743
  1. Petach-Tikva,
Male
9 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE SGA and Growth
Intervention  ICMJE
  • Drug: growth hormone and gonadotropin-releasing hormone agonist
    GH & GNRHa treatment
  • Drug: growth hormone
    GH treatment
Study Arms  ICMJE
  • Experimental: 1
    GH & GNRHa treatment
    Intervention: Drug: growth hormone and gonadotropin-releasing hormone agonist
  • Active Comparator: 2
    GH treatment
    Intervention: Drug: growth hormone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2007)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 9 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00522743
Other Study ID Numbers  ICMJE rmc073243ctil
SGA boys 3243
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Moshe Phillip, Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Moshe Phillip, ProfessorRabin Medical Center
PRS Account Rabin Medical Center
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP