Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

This study has been completed.

Sponsors and Collaborators:	Nemours Children's Clinic AstraZeneca Genentech EMD Serono
Information provided by:	Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT00133354

Purpose

The purpose of this study is to see if Arimidex, an aromatase inhibitor, can delay epiphyseal fusion and increase predicted adult height in boys who are growth hormone deficient, in puberty, and who are taking growth hormone. This is a double blind, placebo controlled 3 year trial.

Condition	Intervention	Phase
Hypopituitarism	Drug: Arimidex (Anastrozole)	Phase II Phase III

Drug Information available for: Anastrozole Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind Trial Investigating the Safety and Efficacy of the Inhibitor Anastrozole (ARIMIDEX) in Delaying Epiphyseal Fusion and Increasing Height Potential of Adolescent Males With Growth Hormone (GH) Deficiency

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:

The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.

Secondary Outcome Measures:

The secondary objective is to determine the effect of Arimidex® treatment in bone mineralization in pubertal GH deficient males treated concurrently with growth hormone.

Estimated Enrollment:	50
Study Start Date:	November 2001
Estimated Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	11 Years to 18 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Growth hormone deficient by formal testing with two provocative agents.
Treated with growth hormone for a minimum of 6 months prior to study entry.
Growth hormone doses must be maintained at 0.2-0.4mg/kg/wk while in protocol.
Stable organic pathology
Presence of puberty [genital Tanner Stage > II (>4cc testicular volume)]
Bone age (BA) > or = 11.5 years and < 15 years

Exclusion Criteria:

Participation in any other trial involving hormone therapy for at least 6 months prior.
Chronic illnesses requiring long term medication that impair growth. (Stable patients with occasional asthma, patients on Ritalin or Adderall or patients on topical acne medication may be included).
Hereditary disease diagnosed clinically.
Moderate to severe scoliosis.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133354

Locations

United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207

Sponsors and Collaborators

Nemours Children's Clinic

AstraZeneca

Genentech

EMD Serono

Investigators

Principal Investigator:

Nelly Mauras, MD

Nemours Children's Clinic

More Information

Study ID Numbers:	IRUSANAS0008, M2372s, 23381
Study First Received:	August 19, 2005
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00133354
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nemours Children's Clinic:

Puberty
Growth hormone deficiency
aromatase inhibitors

estrogen
bone mineral density
short stature

Study placed in the following topic categories:

Hypopituitary dwarfism
Hypothalamic Diseases
Anastrozole
Pituitary Diseases
Hypopituitarism
Endocrine System Diseases

Central Nervous System Diseases
Endocrinopathy
Dwarfism, Pituitary
Brain Diseases
Growth hormone deficiency

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

Nervous System Diseases
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009