Aromatase Inhibitors, Alone And In Combination With Growth Hormone In Adolescent Boys With Idiopathic Short Stature

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

When treating very short children in puberty we are time-limited, as sex hormones cause the growth plates to fuse and growth to end. Growth Hormone (GH), plus drugs that stop puberty, increase height potential, but leave children sexually infantile at a critical time in development. Human and animal data show that estrogen, in females and males, is a principal regulator of the fusion of the growth plate in puberty. Using aromatase inhibitors (AIs), which block testosterone to estrogen conversion, in boys with different growth disorders, we have shown that AIs may have beneficial effects enhancing height potential in growth-retarded males, without affecting their puberty. However, no direct comparison of the effect of AIs alone vs. conventional GH treatment has been done to date. This study will assess the effect of AIs alone, GH alone and combination treatment in enhancing height potential in adolescent boys with idiopathic short stature.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A 4 Year Combination Therapy of Growth Hormone and (GnRH) Agonist in Children With a Short Predicted Height

NCT00840944

Idiopathic Short Stature

UNKNOWN PHASE4

Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

NCT00133354

Hypopituitarism

COMPLETED PHASE2/PHASE3

Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders

NCT07221851

Turner Syndrome Short Stature Homeobox Gene Mutation Idiopathic Short Stature +1 more

RECRUITING PHASE3

Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin

NCT00488124

Idiopathic Short Stature

COMPLETED PHASE2

Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

NCT00355030

Idiopathic Short Stature (ISS)

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Short Stature

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Aromatase Inhibitor

Anastrozole 1mg or Letrozole 2.5mg daily orally for 2 to 3 years

Group Type ACTIVE_COMPARATOR

Aromatase Inhibitor

Intervention Type DRUG

Growth Hormone

Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Group Type ACTIVE_COMPARATOR

Growth Hormone

Intervention Type DRUG

Aromatase Inhibitor and Growth Hormone

Anastrozole 1mg or Letrozole 2.5mg orally daily for 2 to 3 years and Somatropin 0.3mg/kg/week divided daily subcutaneously for 2 to 3 years

Group Type ACTIVE_COMPARATOR

Aromatase Inhibitor

Intervention Type DRUG

Growth Hormone

Intervention Type DRUG

Aromatase Inhibitor and Growth Hormone

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aromatase Inhibitor

Intervention Type DRUG

Growth Hormone

Intervention Type DRUG

Aromatase Inhibitor and Growth Hormone

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Arimidex (Anastrozole) Femara (Letrozole) Nutropin (Somatropin) Genotropin (Somatropin) Arimidex (Anastrozole) Femara (Letrozole) Nutropin (Somatropin) Genotropin (Somatropin)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males: Ages: 12 - less than 18 years.
* Bone age less than 14 ½ years at study initiation.
* Presence of puberty.
* Idiopathic short stature will be defined as a short child equal or less than -2SD for height, with normal GH responses to stimuli (\> or = 5ng/ml to at least 2 secretagogues) or a normal IGF-I and BP-3, normal body proportions and no other identifiable growth pathology.
* Accurate growth data for at least 6 months at baseline is available.

Exclusion Criteria

* Chronic illnesses.
* Chronic use of glucocorticosteroids.
* Previous use of hormonal treatment with AIs, sex steroids or GH in the preceding 6 months.
* Birth weight small for gestational age (SGA).

Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No