Short Stature Related Distress
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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 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 |
- 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
- 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:
- Implicit Association Test
- Masculine Self Image
- Pictures Projective Test
- The Rosenberg Self Esteem Scale-a self report measure of explicit self- esteem
- Quality of Life Questionnaire
- 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
- Child Behavior Checklist
Eligibility| Ages Eligible for Study: | 8 Years to 13 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Boys at the age range of 8-13
- Tanner stage 1
- For the ISS group- more than 2 SD's below the average height
Exclusion Criteria:
- Mental retardation,
- Psychiatric illness,
- Lack of informed consent\assent.
- Health status that required chronic treatment with steroids
Contacts and Locations| Contact: Moshe Phillip, Prof | 972-3-9253747 | mosheph@clalit.org.il |
| Contact: Alona Hamou, Msc | 972-3-9253778 | alonah@clalit.org.il |
| 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 | |
| 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: | March 5, 2013 |
| 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 May 16, 2013