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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00522743
• Date of registration: 29/08/2007
• Prospective Registration: No
• Primary sponsor: Rabin Medical Center
• Public title: Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.
• Scientific title: 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
• Date of first enrolment: May 2005
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00522743
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Israel

Contacts

• Name: Moshe Phillip, Professor
• Affiliation: Rabin Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 9 Years
Age maximum: 13 Years
Gender: Male

Health Condition(s) or Problem(s) studied

SGA and Growth

Intervention(s)

Drug: growth hormone

Drug: growth hormone and gonadotropin-releasing hormone agonist

Primary Outcome(s)

Height measurements [Time Frame: every 3 monthes, during all study period]

Secondary Outcome(s)

IGF-1 concentration [Time Frame: every 6 monthes, during all study period]

Bone age [Time Frame: once a year, during all study period]

Prepubertal changes [Time Frame: every 3 monthes during all study peiod]

Psychological questionnaire [Time Frame: once a year, during all study peiod]

quality of life questionnaire [Time Frame: once a year, during all study period]

Hormone profile, Lipid and lipoprotein concentrations [Time Frame: once a year during all study period]

Secondary ID(s)

rmc073243ctil

SGA boys 3243

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer