Short StaturePhase 4NCT02137538

Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

A Phase 4 study testing Letrozole and Anastrozole in people with Short Stature, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. Read more about this study

Who is it for?: Ages 10 to 17 years, men only
Conditions the study is for: Short Stature
What is being tested?: Letrozole and Anastrozole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2009to 5 Jun 2018
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 to 17 years
Men only
No healthy volunteers
Child

Who may be able to join

Current height less than 5th percentile AND/OR
Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl

Who cannot join

Bone age reading more than 14.0 years
Follicle stimulating hormone > 20 IU/L

Trial locations and contacts

1 site in 1 country.

United States1 site

Lucile Packard Children's Hospital
Palo Alto, California, 94301

Other trials in United States

About this study

Official title: Randomization to Letrozole vs. Anastrozole in Short Pubertal Males

Conditions: Short Stature
Being tested: Letrozole, Anastrozole
Medical subject headings: Dwarfism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LetrozoleDrug
AnastrozoleDrug

Study groups in NCT02137538
Study group	Role	What they receive
Letrozole	Active comparator	Letrozole 2.5 mg daily Receives: Drug: Letrozole
Anastrozole	Active comparator	Anastrozole 1 mg daily Receives: Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Predicted Adult Height at Year 3
Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment.
Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age).
Measured: Year 3

Secondary outcomes (10)

Serum Testosterone
Measured: Baseline, year 3
Dihydrotestosterone
Measured: Baseline, year 3
Androstenedione
Measured: Baseline, year 3
Luteinizing Hormone
Measured: Baseline, year 3
Follicle Stimulating Hormone
Measured: Baseline, year 3
Insulin-like Growth Factor Type 1
Measured: Baseline, year 3
Inhibin B
Measured: Baseline, year 3
Estradiol
Measured: Baseline, year 3
Estrone
Measured: Baseline, year 3
Number of Adverse Events Related to Acne or Bone Fracture
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 20095 Jun 2018

First posted14 May 2014 (estimated)
Study start18 Nov 2009
Primary completion5 Jun 2018
Study completion5 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Short StatureStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02137538
Sponsor's protocol ID: AI growth study
Status last verified: Jun 2021
First submitted: 5 May 2014
Last updated: 15 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Neely EK, Kumar RB, Payne SL, Ranadive SA, Suchet DI. Letrozole vs anastrozole for height augmentation in short pubertal males: first year data. J Clin Endocrinol Metab. 2014 Nov;99(11):4086-93. doi: 10.1210/jc.2014-2432. Epub 2014 Aug 19.
PubMed 25137428

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders

All Short Stature trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomization to Letrozole vs. Anastrozole in Short Pubertal Males
ClinicalTrials.gov ID: NCT02137538
Acronym / sponsor ID: AI growth study
Conditions: Short Stature
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 18 Nov 2009 (actual)
Primary completion: 5 Jun 2018 (actual)
Study completion: 5 Jun 2018 (actual)
First posted: 14 May 2014 (estimated)
Results: Posted 15 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Letrozole	Active comparator	Drug: LetrozoleLetrozole 2.5 mg daily
Anastrozole	Active comparator	Drug: AnastrozoleAnastrozole 1 mg daily

Who may qualify

Ages: 10 to 17 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Current height less than 5th percentile AND/OR
Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl

Key exclusion criteria (2 listed)

Bone age reading more than 14.0 years
Follicle stimulating hormone > 20 IU/L

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
Letrozole	Drug	Letrozole
Anastrozole	Drug	Anastrozole

Primary outcome

Predicted Adult Height at Year 3
Time frame: Year 3
Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment. Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age).

10 secondary outcomes

Serum Testosterone
Time frame: Baseline, year 3
Dihydrotestosterone
Time frame: Baseline, year 3
Androstenedione
Time frame: Baseline, year 3
Luteinizing Hormone
Time frame: Baseline, year 3
Follicle Stimulating Hormone
Time frame: Baseline, year 3
Insulin-like Growth Factor Type 1
Time frame: Baseline, year 3
Inhibin B
Time frame: Baseline, year 3
Estradiol
Time frame: Baseline, year 3
Estrone
Time frame: Baseline, year 3
Number of Adverse Events Related to Acne or Bone Fracture
Time frame: 3 years

Results and safety

Results posted to the registry on 15 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Letrozole	39	23
Anastrozole	40	26

Primary outcome: Predicted Adult Height at Year 3

Time frame: Year 3. Mean (Standard Deviation). Unit: cm

Measure	Letrozole n = 30	Anastrozole n = 35
Value	167.8 (5.8)	169.4 (5.1)

Population analysed: Participants who finished the first year of therapy are included in the analysis, excluding participants who had received growth hormone.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Letrozole	0 of 39 (0%)	12 of 39 (30.8%)	0 of 39
Anastrozole	2 of 40 (5%)	10 of 40 (25%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25137428Neely EK, Kumar RB, Payne SL, Ranadive SA, Suchet DI. Letrozole vs anastrozole for height augmentation in short pubertal males: first year data. J Clin Endocrinol Metab. 2014 Nov;99(11):4086-93. doi: 10.1210/jc.2014-2432. Epub 2014 Aug 19.
Individual participant dataSharing planned: No

Related trials for Short Stature

RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Primordial Dwarfism Registry
MOPDII, Meier-Gorlin Syndrome
Recruiting
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Idiopathic Short Stature
RecruitingObservational study
Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
Congenital Hypothyroidism, Neurodevelopmental Disorders

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.

E Kirk Neely, MD principal investigator

Stanford University

Laura K Bachrach, MD principal investigator

Stanford University

Walter A Zegarra, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Letrozole and Anastrozole in people with Short Stature, run by Stanford University 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 3 inclusion and 2 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 15 Jul 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Predicted Adult Height at Year 3 (time frame: Year 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137538, which also lists 1 linked publication.

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 15 Jul 2021.