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Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00133354
First Posted: August 23, 2005
Last Update Posted: October 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
AstraZeneca
Genentech, Inc.
EMD Serono
Information provided by (Responsible Party):
Nelly Mauras, Nemours Children's Clinic
  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) Drug: Placebo Drug: Growth Hormone Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Nelly Mauras, 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. [ Time Frame: 12months, 24months, 36months ]

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. [ Time Frame: 12months, 24months, 36months ]

Enrollment: 53
Study Start Date: November 2001
Study Completion Date: August 2010
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arimidex and Growth Hormone Drug: Arimidex (Anastrozole)
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.
Drug: Growth Hormone
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.
Placebo Comparator: Placebo and Growth Hormone Drug: Placebo
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.
Drug: Growth Hormone
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.

  Eligibility

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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00133354


Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
AstraZeneca
Genentech, Inc.
EMD Serono
Investigators
Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic
  More Information

Responsible Party: Nelly Mauras, Chief, Division of Endocrinology, Diabetes & Metabolism, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00133354     History of Changes
Other Study ID Numbers: IRUSANAS0008
M2372s
23381
First Submitted: August 19, 2005
First Posted: August 23, 2005
Last Update Posted: October 12, 2011
Last Verified: October 2011

Keywords provided by Nelly Mauras, Nemours Children's Clinic:
Puberty
Growth hormone deficiency
aromatase inhibitors
estrogen
bone mineral density
short stature

Additional relevant MeSH terms:
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists