Bicalutamide plus Anastrozole for the Treatment of Gonadotropin-Independent Precocious Puberty in Boys with Testotoxicosis: A Phase II, Open-Label Pilot Study (BATT)
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Edward O. Reiter
ABSTRACT
Objective: To evaluate the efficacy, tolerability, and pharmacokinetics of bicalutamide plus anastrozole in young males with testotoxicosis.
Methods: This was a multicenter, open-label, single-arm, 12-month, Phase II pilot trial in 14 males (2-9 years) with testotoxicosis treated with bicalutamide (12.5, 25, 50, or 100 mg) and anastrozole (0.5 or 1 mg) daily. The primary outcome was change in growth rate.
Results: At 1 year, the mean (standard deviation) change from baseline in growth rate was -1.6 (± 5.1) cm/year and -0.1 (± 1.8) SD units, and in bone maturation was -2.3 (± 0.5) years. The bone age/chronological age ratio was reduced from 2.1 (± 0.6) at baseline to 1.0 (± 0.4) (p = 0.00013). Steady-state trough R-bicalutamide and anastrozole concentrations were attained by Day 21 and 8, respectively. Gynecomastia (42.9%) and breast tenderness (12.5%) were the most common treatment-related adverse events.
Conclusions: Treatment of testotoxicosis with bicalutamide plus anastrozole resulted in slower growth rate.
© Freund Publishing House Ltd.
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Articles in the same Issue
- A Warning Sign from the Thyroid
- Variable Associations of Klinefelter Syndrome in Children
- Diabetes Insipidus in a Young Child
- Evaluation and Follow-up of Clinically Euthyroid Children with Normal Free T4 and Suppressed TSH
- Bicalutamide plus Anastrozole for the Treatment of Gonadotropin-Independent Precocious Puberty in Boys with Testotoxicosis: A Phase II, Open-Label Pilot Study (BATT)
- Endocannabinoid (EC) Receptor, CB1, and EC Enzymes' Expression in Primary Adipocyte Cultures of Lean and Obese Pre-pubertal Children in Relation to Adiponectin and Insulin
- The Relationship of Insulin Secretion and GAD65 Antibody Levels at Diagnosis on Glycemic Control in Type 2 Diabetes
- Morning Cortisol is Not Associated with Truncal Fatness or Resting Blood Pressure in Children: Cross-Sectional and 1-2 Year Follow-Up Analyses
- Decreased Plasma Apelin Levels in Pubertal Obese Children
- Adolescent Acromegaly: Clinical Parameters and Treatment Outcome
- Left Ventricular Diastolic Dysfunction in Adolescents with Type 1 Diabetes Reflects the Long- but Not Short- Term Metabolic Control
- Effects of a Structured Exercise Program on Insulin Resistance, Inflammatory Markers and Physical Fitness in Obese Korean Children
- Case Series of Neonatal Hypocalcemia due to Pseudohypoparathyroidism
- A Case of Antenatal Bartter Syndrome with Sensorineural Deafness
- Association of SUMO4 M55V Polymorphism with Type 1 Diabetes in Chinese Children
- Mayer-Rokintansky-Kuster-Hauser Syndrome Associated with Atrial Septal Defect, Partial Anomalous Pulmonary Venous Connection and Unilateral Kidney – An Unusual Triad of Anomalies
