Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Stanford University

Status and phase: Completed; Phase 4

Conditions: Short Stature

Treatments: Drug: Letrozole; Drug: Anastrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT02137538

AI growth study

Details and patient eligibility

About

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. It also should determine if there are differences in the side effect profiles of the two drugs to be used.

Enrollment: 79 patients

Sex: Male

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Letrozole

Active Comparator group

Description:

Letrozole 2.5 mg daily

Treatment:

Drug: Letrozole

Anastrozole

Active Comparator group

Description:

Anastrozole 1 mg daily

Treatment:

Drug: Anastrozole