NCT01246219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

6.1 years

First QC Date

November 16, 2010

Last Update Submit

December 18, 2017

Conditions

Idiopathic Short StatureSelf Image

Keywords

Idiopathic Short statureSelf ImageGH therapyPsychological distress

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (2)

  • Perceived self image score

    After 4 years of treatment

  • Perceived self image score

    After 4 years of treatment

Study Arms (3)

GH treatment

EXPERIMENTAL

4 years of GH treatment

Drug: GH treatment (Genotropin)

Placebo

PLACEBO COMPARATOR

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

Non treatment group

NO INTERVENTION

Interventions

GH treatment (Genotropin)DRUG

4 years treatment with GH

GH treatment
1 year treatment with placebo followed by optional 3 years of GH treatmentDRUG

1 year treatment with placebo followed by optional 3 years of GH treatment

Placebo

Eligibility Criteria

Age8 Years - 17 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Mental retardation,
  • Psychiatric illness,
  • Lack of informed consent\\assent.
  • Health status that required chronic treatment with steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schneider Children's Medical center

Petah Tikva, 49202, Israel

Location

Related Publications (1)

  • 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.

    PMID: 30721549DERIVED

MeSH Terms

Interventions

Human Growth HormoneTherapeutics

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Moshe Phillip, Prof

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 23, 2010

Study Start

October 1, 2011

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

IL(1)