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Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys

NCT ID: NCT00133354

Last Updated: 2011-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypopituitarism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arimidex and Growth Hormone

Group Type ACTIVE_COMPARATOR

Arimidex (Anastrozole)

Intervention Type 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.

Growth Hormone

Intervention Type 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.

Placebo and Growth Hormone

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Growth Hormone

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

EMD Serono

INDUSTRY

Sponsor Role collaborator

Nemours Children's Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nelly Mauras

Chief, Division of Endocrinology, Diabetes & Metabolism

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nelly Mauras, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Clinic

Locations

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Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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M2372s

Identifier Type: -

Identifier Source: secondary_id

23381

Identifier Type: -

Identifier Source: secondary_id

IRUSANAS0008

Identifier Type: -

Identifier Source: org_study_id