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Short Stature Related Distress

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ClinicalTrials.gov Identifier: NCT01246219
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rabin Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment 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

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Actual Study Start Date : October 2011
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Psychological Distress score [ Time Frame: After 4 years of treatment ]
    short stature related distress score as measured by the Height Perception Pictures Test

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

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

  4. 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 :
  1. Perceived self image score [ Time Frame: After 4 years of treatment ]
    Perceived self image score as measured through Single Category Implicit Association Test

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


Eligibility Criteria
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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
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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
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Israel
Schneider Children's Medical center
Petach-Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
Pfizer
Investigators
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Principal Investigator: Moshe Phillip, Prof Rabin Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01246219    
Other Study ID Numbers: rmc004981ctil
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Keywords provided by Rabin Medical Center:
Idiopathic Short stature
Self Image
GH therapy
Psychological distress
Additional relevant MeSH terms:
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Dwarfism
Bone Diseases, Developmental
Bone Diseases
 Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases