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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Collaborator: Pfizer
• Treatments: Hormones

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