We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Short Stature Related Distress

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01246219
First Posted: November 23, 2010
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rabin Medical Center
  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 Idiopathic Short Stature (ISS) 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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:
  • Psychological Distress score [ Time Frame: After 4 years of treatment ]
    short stature related distress score as measured by the Height Perception Pictures Test

  • Psychological Distress score [ Time Frame: After 4 years of treatment ]
    short stature related distress score as measured by the Rosenberg Self-Esteem Scale

  • Psychological Distress score [ Time Frame: After 4 years of treatment ]
    short stature related distress score as measured by the Quality of Life questionnaire

  • Psychological Distress score [ Time Frame: After 4 years of treatment ]
    short stature related distress score as measured by Silhouette Apperception Technique questionnaire


Secondary Outcome Measures:
  • Perceived self image score [ Time Frame: After 4 years of treatment ]
    Perceived self image score as measured through Single Category Implicit Association Test

  • Perceived self image score [ Time Frame: After 4 years of treatment ]
    Perceived self image score as measured through the Masculine Self Image questionnaire


Estimated Enrollment: 90
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2017 (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

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. Patients in Segment 2 will be evaluated only once.

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

  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. Silhouette Apperception Technique (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1 Segment 1 :Boys at the age range of 8-13 years 2. Segment 2: Boys at the age range of 12-17 years 3. Tanner stage 1 (segment 1 only) 4. 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246219


Locations
Israel
Schneider Children's Medical center
Petach-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Pfizer
Investigators
Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
  More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01246219     History of Changes
Other Study ID Numbers: rmc004981ctil
First Submitted: November 16, 2010
First Posted: November 23, 2010
Last Update Posted: October 4, 2017
Last Verified: September 2017

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