The primary objective of this study is to investigate whether bicalutamide given in combination with anastrozole once daily for 12 months is effective in treating testotoxicosis in boys. Testotoxicosis is a condition that causes early puberty in boys including growth in height, and development of muscles and sexual organs .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
oral
oral
Research Site
Birmingham, Alabama, United States
Research Site
Jacksonville, Florida, United States
Research Site
Indianapolis, Indiana, United States
Change in Growth Rate (cm/Year)
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, based on raw height data (cm/year).
Time frame: Assessed after 12 months treatment
Change in Growth Rate (SD Units)
Change in growth rate after 12 months relative to the growth rate during the ≥6 month pre-study period, calculated after adjustment for the chronological age of the patient (expressed as a standard deviation \[SD\] score).
Time frame: Assessed after 12 months treatment
Change in Growth Rate (cm/Year)
Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.
Time frame: Assessed after 6 months treatment
Change in Growth Rate (SD Units)
Change in growth rate after 6 months of treatment relative to the growth rate during the ≥6 months pre-study period.
Time frame: Assessed after 6 months treatment
Change in Bone Age Maturation Rate (cm/Year)
Radiographs were used to assess the bone age at ≥6 months pre-study, baseline, 6 and 12 months. The rate of change in bone age at baseline was calculated from a radiograph taken at least 6 months prior to study enrolment. The change in bone maturation after 6 months of treatment was calculated relative to the rate of change in bone age during the ≥ 6 months pre-study period.
Time frame: Assessed after 6 and 12 months treatment
Change in Bone Age to Chronological Age Ratio
Change in bone age to chronological age ratio after 6 and 12 months treatment relative to the baseline ratio for all patients.
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Research Site
Minneapolis, Minnesota, United States
Research Site
Tulsa, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Greenville, South Carolina, United States
Research Site
Temple, Texas, United States
Research Site
Spokane, Washington, United States
Research Site
London, Ontario, Canada
...and 5 more locations
Time frame: Assessed after 6 and 12 months of treatment
Number of Patients With Height Between 5th and 95th Percentile
The number of patients whose height lies between the 5th and 95th percentiles (using the percentile tables on the WHO database) for chronological age at the 12 month assessment.
Time frame: Assessed after 3, 6, 9 and 12 months of treatment
Change in Predicted Adult Height (PAH)
Radiographs are used to assess the bone age, the change in predicted adult height (PAH) is calculated from the bone age using the Bayley and Pinneau Method. The change in PAH is be calculated by subtracting the PAH at baseline from the PAH at 12 months.
Time frame: Assessed after 12 months treatment
Change in Average Testicular Volume
Testicular volume of both testes was measured using either ultrasound or an orchidometer. Testicular volume was measured at baseline and at 6 and 12 months. The change in testicular volume from baseline was calculated for the left and right testicle as well as the average across both testes by subtracting the baseline volume from the volumes at 6 and 12 months within each patient.
Time frame: Assessed after 6 and 12 months of treatment