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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GH treatment | Experimental | 4 years of GH treatment |
|
| Placebo | Placebo Comparator | 1 year treatment with placebo followed by optional 3 years of GH treatment |
|
| Non treatment group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GH treatment (Genotropin) | Drug | 4 years treatment with GH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological Distress score | short stature related distress score as measured by the Height Perception Pictures Test | After 4 years of treatment |
| Psychological Distress score | short stature related distress score as measured by the Rosenberg Self-Esteem Scale | After 4 years of treatment |
| Psychological Distress score | short stature related distress score as measured by the Quality of Life questionnaire | After 4 years of treatment |
| Psychological Distress score | short stature related distress score as measured by Silhouette Apperception Technique questionnaire | After 4 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived self image score | Perceived self image score as measured through Single Category Implicit Association Test | After 4 years of treatment |
| Perceived self image score | Perceived self image score as measured through the Masculine Self Image questionnaire |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Moshe Phillip, Prof | Rabin Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical center | Petah Tikva | 49202 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30721549 | Derived | Shemesh-Iron M, Lazar L, Lebenthal Y, Nagelberg N, Tenenbaum A, Ezra R, Leffler N, Yackobovitch-Gavan M, Schoenberg-Taz M, Phillip M. Growth hormone therapy and short stature-related distress: A randomized placebo-controlled trial. Clin Endocrinol (Oxf). 2019 May;90(5):690-701. doi: 10.1111/cen.13944. Epub 2019 Mar 7. |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| 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 |
|
| After 4 years of treatment |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |