Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA. - Full Text View

Sponsored by:	Rabin Medical Center
Information provided by:	Rabin Medical Center
ClinicalTrials.gov Identifier:	NCT00522743

Purpose

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.

Condition	Intervention
SGA and Growth	Drug: growth hormone and gonadotropin-releasing hormone agonist Drug: growth hormone

Drug Information available for: Insulin-like growth factor I Mecasermin rinfabate Somatotropin Somatropin Gonadorelin Gonadorelin hydrochloride LH-RH

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:

Height measurements [ Time Frame: every 3 monthes, during all study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IGF-1 concentration [ Time Frame: every 6 monthes, during all study period ] [ Designated as safety issue: Yes ]
Hormone profile, Lipid and lipoprotein concentrations [ Time Frame: once a year during all study period ] [ Designated as safety issue: No ]
Prepubertal changes [ Time Frame: every 3 monthes during all study peiod ] [ Designated as safety issue: No ]
Bone age [ Time Frame: once a year, during all study period ] [ Designated as safety issue: No ]
quality of life questionnaire [ Time Frame: once a year, during all study period ] [ Designated as safety issue: No ]
Psychological questionnaire [ Time Frame: once a year, during all study peiod ] [ Designated as safety issue: No ]

Enrollment:	17
Study Start Date:	May 2005
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental GH & GNRHa treatment	Drug: growth hormone and gonadotropin-releasing hormone agonist GH & GNRHa treatment
2: Active Comparator GH treatment	Drug: growth hormone GH treatment

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Eligibility

Ages Eligible for Study:	9 Years to 13 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Boys
IUGR
Ages 10-13
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)
Prepubertal (tanner stage 1) at commencement of trail
Peak GH above 10ng/ml in at least one provocative test for GH secretion 7.Signed informed consent

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00522743

Locations

Israel
Schnider children medical center
Petach-Tikva, Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator:

Moshe Phillip, Professor

Rabin Medical Center

More Information

Responsible Party:	Rabin Medical Center ( Prof. Moshe Phillip )
Study ID Numbers:	rmc073243ctil, SGA boys 3243
Study First Received:	August 29, 2007
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00522743
Health Authority:	Israel: Ministry of Health

Keywords provided by Rabin Medical Center:

SGA
GH
GnRHa
IGF-1

ClinicalTrials.gov processed this record on January 16, 2009