A Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety & Efficacy of Anastrozole (ARIMIDEX) in Increasing Predicted Adult Height of Adolescent Makes with Growth Hormone Deficiency

Principal Investigator: Nelly Mauras

Funding: Astra Zeneca

In the last few years, it has become clear that the process of completion of linear growth is primarily dependent on the production of estrogen, even in boys. Hence, when children go through puberty, they have a rapid growth spurt, but they also finish growing because of the presence of estrogen. Men convert testosterone to estrogen through a process mediated by an enzyme called aromatase. We are investigating the safety and efficacy of prolonged selective estrogen production using an inhibitor of this enzyme, (Arimidex) in pubertal boys with growth hormone deficiency. Fifty-two subjects have been recruited in collaboration with six other centers and patients have been treated already for over two years. Blood samples for hormones and growth factors, bone ages, DXAs and anthropometry are measured at periodic intervals and all data gathered at Nemours Jacksonville as the central site. Changes in predicted adult height are the ultimate outcome of the study although most of the subjects will be followed through the completion of their final adult height. The results of these studies will likely offer a new an important alternative treatment for boys with disordered growth.