HypopituitarismPhase 2/3NCT00133354
Arimidex Multicenter Trial in Growth Hormone (GH) Deficient Boys
A Phase 2/3 study testing Arimidex (Anastrozole) and Growth Hormone in people with Hypopituitarism, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years, men only
- Conditions the study is for
- Hypopituitarism
- What is being tested?
- Arimidex (Anastrozole) and Growth Hormone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2001to Aug 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this 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
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
- Being tested
- Arimidex (Anastrozole), Placebo, Growth Hormone
- Keywords
- Puberty, Growth hormone deficiency, aromatase inhibitors, estrogen, bone mineral density, short stature
- Medical subject headings
- Hypopituitarism, Dwarfism, Pituitary, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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 HormoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Arimidex and Growth Hormone | Active comparator | Not described Receives: Drug: Arimidex (Anastrozole); Drug: Growth Hormone |
| Placebo and Growth Hormone | Placebo comparator | Not described Receives: Drug: Placebo; Drug: Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
Measured: 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.
Measured: 12months, 24months, 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startNov 2001
- Primary completionAug 2006
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypopituitarismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Genentech, Inc., EMD Serono
- Responsible party
- Principal investigator, Nelly Mauras, Nemours Children's Clinic
- Investigators
- Nelly Mauras, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133354
- Sponsor's protocol ID
- IRUSANAS0008
- Other IDs
- M2372s, 23381
- Status last verified
- Oct 2011
- First submitted
- 19 Aug 2005
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00133354
- Acronym / sponsor ID
- IRUSANAS0008
- Conditions
- Hypopituitarism
- Keywords
- Puberty, Growth hormone deficiency, aromatase inhibitors, estrogen, bone mineral density, short stature
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- AstraZeneca, Genentech, Inc., EMD Serono
- Study start
- Nov 2001
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 23 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arimidex and Growth Hormone | Active comparator | Drug: Arimidex (Anastrozole), Drug: Growth Hormone |
| Placebo and Growth Hormone | Placebo comparator | Drug: Placebo, Drug: Growth Hormone |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)]
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arimidex and Growth Hormone |
| PlaceboSubjects 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 | Placebo and Growth Hormone |
| Growth HormoneGH (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. | Drug | Arimidex and Growth Hormone, Placebo and Growth Hormone |
Primary outcome
The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement.
Time frame: 12months, 24months, 36months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Mauras, MD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Arimidex (Anastrozole) and Growth Hormone in people with Hypopituitarism, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary measure of efficacy is change in predicted adult height based on rate of bone age advancement. (time frame: 12months, 24months, 36months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2011.