magic foundation for children's growth - : Clinical Trials and Studies

Study Design: Multi-centre, open-label, observational

Study Duration:12 months treatment* followed by annual follow-up visits until final adult height achieved

Target Recruitment: 20 patients

First Patient Enrolled: November 2004 – Recruitment until April 2007

*Patients completing 12-month treatment phase can continue treatment for as long as their treating physician considers it beneficial

Study Rationale

Testotoxicosis is characterised by sexual precocity, rapid growth velocity, and premature epiphyseal fusion driven by testosterone and oestradiol. Because antiandrogens have been shown to inhibit peripheral androgen activity at the receptor level, and aromatase inhibitors reduce oestrogen levels by blocking the conversion of androgens to oestrogens, treatment with a combination of an antiandrogen (bicalutamide) and an aromatase inhibitor (anastrozole) is being evaluated in this condition .

Study Details

•Approximately 20 patients

•12-month treatment

•Inclusion criteria:

- Boys >2 years

- Naïve to antiandrogen therapy

•Exclusion criteria:

- Evidence of central precocious puberty (based on GnRH stimulation test)

- Liver function > 1.5x upper limit

•Outcome variables:

- Change in growth rate after 12 months of treatment

- Change in growth rate after 6 months treatment

- Change in rate of bone age maturation after 6 and 12 months treatment

-Change in predicted adult height (PAH) after 12 months of treatment

- Evaluation of testicular volume, Tanner staging, acne and aggressive behaviour at 3, 6 and 12 months

-Safety

§ Planned centres in: South Africa, US, South America, Germany, Russia and UK . Will consider other regions.

If you are interested in taking part in the trial and require further details or information about participation in this trial please contact:

Dr. James Vasselli
Clinical Study Physician
AstraZeneca
C2C-101
1800 Concord Pike
PO Box 15437
Wilmington DE 19850-5437

or contact AstraZeneca Information Center at: 1-800-236-9933.