Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

NCT00133354 | Completed Phase 2 DMC

• 3 other identifiers: IRUSANAS0008M2372s23381
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypopituitarism

Keywords

Puberty; Growth hormone deficiency; aromatase inhibitors; estrogen; bone mineral density; short stature

Outcome Measures

Primary Outcomes (1)

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

  12months, 24months, 36months

Secondary Outcomes (1)

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

  12months, 24months, 36months

Study Arms (2)

Arimidex and Growth Hormone

ACTIVE COMPARATOR

Drug: Arimidex (Anastrozole); Drug: Growth Hormone

Placebo and Growth Hormone

PLACEBO COMPARATOR

Drug: Placebo; Drug: Growth Hormone

Interventions

Arimidex (Anastrozole) DRUG

Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.

Arimidex and Growth Hormone

Placebo DRUG

Subjects will be randomized in a 1:1 ratio to be given either Arimidex 1 mg or placebo orally. Subjects will receive trial treatment for 36 months while continued on GH.

Placebo and Growth Hormone

Growth Hormone DRUG

GH (Nutropin®, Genentech, So. San Francisco, CA) will be administered throughout the trial at a dose of \~0.3mg/kg.w (no more than 0.4mg/kg.w) given subcutaneously (SC) at bedtime daily. Dose adjustments on the GH dose will be made by the investigator at least every 6mo.

Arimidex and Growth Hormone; Placebo and Growth Hormone

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• AstraZeneca: collaborator
• Genentech, Inc.: collaborator
• EMD Serono: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Hypopituitarism; Dwarfism, Pituitary; Dwarfism

Interventions

Anastrozole; Growth Hormone

Condition Hierarchy (Ancestors)

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Nelly Mauras, MD

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Endocrinology, Diabetes & Metabolism

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: November 1, 2001
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2010
• Last Updated: October 12, 2011

Record last verified: 2011-10

Locations

US (1)