Biochemical Markers of Growth Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

NCT00458263 | Completed Phase 4

• 1 other identifier: rmc003515ctil
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

One arm, open, prospective, intervention study to assess biochemical markers of growth response to Growth Hormone treatment in 20 Children, aged 3-9 years old, with idiopathic short stature. All participants will be treated with Growth Hormone during the first year of the study (and then in accordance with the local ethic requirement, to supply drug which is not approved for the indication used in the study, for additional 3 years) and then will be followed up for the next 3 years. The impact of Growth Hormone therapy on clinical laboratory parameters that are indicative of the growth response will be assessed by collecting blood and urine samples during the 4 years study period. The primary endpoints are measurements of height and growth velocity during the year of Growth Hormone treatment, the height at the beginning of puberty and final height. Secondary endpoints are psychological parameters, assessed by questionnaires.

Conditions

Idiopathic Short Stature

Keywords

Growth Hormone treatment; ISS; Biochemical markers; Growth response

Outcome Measures

Primary Outcomes (4)

• Height

  every 4 months

• Growth velocity

  every 4 months

• Height at beginning of puberty

  At the biginning of puberty

• Final height

  When acheiving final height

Secondary Outcomes (2)

• Psychological parameters

  once a year

• HbA1c and IGF-1

  at baseline. after 3 months and than every 6 months

Study Arms (1)

single arm

EXPERIMENTAL

Drug: Somatotropin growth hormone recombinant human

Interventions

Somatotropin growth hormone recombinant human DRUG

daily Sub Cutaneous injections

single arm

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages 3 to \<9 years
• Short stature with height \>2.25 Standard Deviation below the mean
• Prepubertal (Tanner stage I) at commencement of trial
• Peak Growth Hormone above 10ng/ml in at least one provocative test for Growth Hormone secretion
• Signing informed consent forms

You may not qualify if:

• Intra Uterine Growth Retardation
• Growth retardation associated with malignancy, severe chronic disease, genetic syndromes and endocrine disorders
• Diabetes
• Treatment with any medical product which may interfere with Growth Hormone

Sponsors & Collaborators

• Rabin Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

schneider children medical center of Israel

Petah Tikva, 49202, Israel

Location

Study Officials

• Moshe Phillip, Prof, MD

  Schneider Children Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2007
• First Posted: April 10, 2007
• Study Start: April 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 3, 2013

Record last verified: 2011-10

Locations

IL (1)