Short Stature Related Distress

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rabin Medical Center
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01246219
First received: November 16, 2010
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

The research aims to provide data on gender-related psychological impact of GH (Growth Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the study, the investigators aim to provide descriptive documentation of the unique distress signal manifestation implicitly shown by ISS (idiopathic short stature)boys and suggest methods of early detection and measurement of such manifestations that can be used to cement guidelines for the treatment in GH.


Condition Intervention Phase
Idiopathic Short Stature
Self Image
Drug: GH treatment (Genotropin)
Drug: 1 year treatment with placebo followed by optional 3 years of GH treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Influence of Growth Hormone (GH) Therapy on Short Stature Related Distress a Prospective Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Distress score [ Time Frame: After 4 years of treatment ] [ Designated as safety issue: No ]
    short stature related distress score as measured by the psychological evaluation


Secondary Outcome Measures:
  • Perceived self image score [ Time Frame: After 4 years of treatment ] [ Designated as safety issue: No ]
    Perceived self image score as measured through the psychological evaluation


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GH treatment
4 years of GH treatment
Drug: GH treatment (Genotropin)
4 years treatment with GH
Placebo Comparator: Placebo
1 year treatment with placebo followed by optional 3 years of GH treatment
Drug: 1 year treatment with placebo followed by optional 3 years of GH treatment
1 year treatment with placebo followed by optional 3 years of GH treatment
No Intervention: Non treatment group
No Intervention: control group - boys with normal stature

Detailed Description:

Study Design:

A prospective randomized, double blind, placebo controlled trial design, comparing four research groups, with 4 repeated psychological measures (before treatment, after 3 months,after 1 year, and at the end of treatment, after 4 years).

The study will be divided into two segments:

Segment 1:double blind, placebo controlled, will include the first 60 ISS (Idiopathic Short Stature)recruited patients. Patients in this segment will be randomized to one of the growth hormone treatment groups in a ratio of 2:1. 40 patients will be treated 4 years with GH and 20 patients will be treated with placebo at the first year of the study and will have the option to start GH treatment after one year, for a duration of 3 years.

Segment 2:after the enrollment to segment 1 will end, enrollment to segment 2 will begin.Participants in segment 2 (patients with ISS and short stature) will serve as control groups and therefore will not be treated with growth hormone.

in addition,30 boys with normal stature will serve as a second control group.

The 4 repeated psychological evaluations (before treatment,after 3 months, after 1 year, and at the end of treatment, after 4 years)will include:

  1. Implicit Association Test
  2. Masculine Self Image
  3. Pictures Projective Test
  4. The Rosenberg Self Esteem Scale-a self report measure of explicit self- esteem
  5. Quality of Life Questionnaire
  6. SAT- a self report measure assessing children's and adolescent's perception of their own body size compared with that of their age-related peers
  7. Child Behavior Checklist
  Eligibility

Ages Eligible for Study:   8 Years to 13 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Boys at the age range of 8-13
  2. Tanner stage 1
  3. For the ISS group- more than 2 SD's (standard deviation) below the average height

Exclusion Criteria:

  1. Mental retardation,
  2. Psychiatric illness,
  3. Lack of informed consent\assent.
  4. Health status that required chronic treatment with steroids
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01246219

Contacts
Contact: Moshe Phillip, Prof 972-3-9253747 mosheph@clalit.org.il
Contact: Alona Hamou, Msc 972-3-9253778 alonah@clalit.org.il

Locations
Israel
Schneider Children's Medical center Recruiting
Petach-Tikva, Israel, 49202
Sub-Investigator: Shlomit Shalitin, Dr         
Sub-Investigator: Liora Lazar, Dr         
Sub-Investigator: Liat de Vries, Dr.         
Sub-Investigator: Yael Lebenthal, Dr         
Sub-Investigator: Revital Nimri, Dr.         
Sub-Investigator: Rachel Fromkin, Dr         
Sub-Investigator: Tal Oron, Dr         
Sub-Investigator: Ariel Tenenbaum, Dr.         
Sub-Investigator: Sharon Demol, Dr         
Sub-Investigator: Tal Ben Ari, Dr         
Sponsors and Collaborators
Rabin Medical Center
Pfizer
Investigators
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  More Information

No publications provided

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01246219     History of Changes
Other Study ID Numbers: rmc004981ctil
Study First Received: November 16, 2010
Last Updated: May 4, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Idiopathic Short stature
Self Image
GH therapy
Psychological distress

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 27, 2014