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A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature | Clinical Trials | Clareo Health

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A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

A Study of the Genetic Determinants of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

NCT05894876•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

The study doctor will collect information from participants with Idiopathic Short Stature, who were treated with growth hormone for at least a year when they were children, before they reached puberty. The word "Idiopathic" refers to "unknown cause", and as such the study participants have/had short stature with no identifiable medical cause. The purpose of the study is to identify differences in the genetic characteristics of participants who responded well or poorly to growth hormone therapy. No medications or other treatments are provided to the participants by Novo Nordisk as part of this study. The study will last for up to 1 year. The participants will attend their usual doctor's appointments. If the participants are not usually visiting the clinic, they will need to do it only once as part of this study. If the participant agrees to take part in the study, they will be asked to read and sign the 'Agreement to take part form'.

Eligibility

Age

3 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed consent/parental consent and patient assent for minor children obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
•Patient has been diagnosed with Idiopathic Short Stature (ISS) and received at least 1 year of GH therapy.
•Patient was prepubertal at initiation of and throughout first year of GH therapy, as determined by the treating physician and patient medical records.
•Patient had no prior exposure to growth promoting therapy prior to initiation of GH therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.
•Age at initiation of GH therapy:
•* Boys: Age above or equal to 3 years and below 11.0 years.
•* Girls: Age above or equal to 3 years and below 10.0 years.
•Impaired height prior to initiation of GH therapy defined as at least 2 standard deviations below the mean height for chronological age and sex according to local growth reference charts. In the absence of local reference charts, the standards of Centres for Disease Control and Prevention should be used.
•GH deficiency has been excluded via GH stimulation test (cut point of 7 nanograms per milliliter \[ng/ml\]) or other clinical and biochemical criteria according to local clinical practice.
•Patient fits within one of the following response groups:
+2 more criteria

Exclusion Criteria

•Previous participation in this study. Participation is defined as having given informed consent in this study.
•Mental incapacity, unwillingness or language barriers precluding adequate understanding, cooperation or informed consent.
•Receipt of any investigational medicinal product within 3 months before or during the first year of GH therapy that could influence response to GH therapy.
•Concomitant illness within 3 months before or during the first year of GH therapy that could (positively or negatively) influence the first year of GH therapy. Exception: Attention Deficit Hyperactive Disorder and its treatment can be included but should be recorded.
•Children with suspected or confirmed growth hormone deficiency according to local practice.
•Concomitant use of medication including gonadotropin-releasing hormone (GnRH) analogues, aromatase inhibitors, sex steroids, glucocorticoids or any other medication that can influence response to GH therapy. Exception: Attention Deficit Hyperactive Disorder and its treatment can be included but should be recorded.
•Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, such as but not limited to:
•* Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
•* Any other disorder that can cause short stature such as, but not limited to, psychiatric disorders, nutritional disorders, chronic systemic illness, chronic respiratory conditions (e.g. asthma), and chronic renal disease.
•* Turner Syndrome (including mosaicism).
+8 more criteria

Locations (4)

[Legal] Children's Hospital of Orange County on behalf of CHOC Children's Hospital of Orange County

Orange, California, United States

Novo Nordisk Investigational Site

Columbia, Maryland, United States

University of Sao Paulo School of Medicine

São Pauloa, Brazil

Assuta Ashdod Division of Pediatric Endocrinology and Diabetes

Ashdod, Israel

Key Dates

Start Date

April 29, 2024

Primary Completion Date

March 21, 2025

Completion Date

March 21, 2025

Last Updated

December 12, 2025

Enrollment

ACTUAL participants

Conditions

Idiopathic Short Stature

Interventions

No treatment is given

OTHER

Skeletal Muscle Effects of GH in Boys

NCT04020913

Growth Hormone DeficiencyIdiopathic Short Stature

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WITHDRAWNPHASE4

Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

NCT01438801

Idiopathic Short Stature

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

Inclusion Criteria

Exclusion Criteria

Skeletal Muscle Effects of GH in Boys

Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

Ghrelin Levels in Children With Poor Growth