Trial Information

Evaluating the Effect of Letrozole With or Without Concomitant Zoledronic Acid on Estrogen Responsive Targets in Postmenopausal Women

OBJECTIVES:

Primary

- Compare the percent change in breast density in healthy postmenopausal women with high
breast density treated with placebo only vs letrozole and placebo vs letrozole and
zoledronate.

- Compare the percent change in biochemical markers of bone turnover in participants
treated with these regimens.

Secondary

- Compare the bone density in participants treated with these regimens.

- Compare growth hormone release and insulin-like growth factor levels in participants
treated with these regimens.

- Compare the incidence and severity of adverse events in participants treated with these
regimens.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter, pilot study.
Participants are stratified according to prior hormone replacement therapy (HRT) use
(discontinued HRT > 5 years ago or no prior HRT use vs discontinued HRT 1-5 years ago).
Patients are randomized to 1 of 3 treatment arms.

- Arm I: Participants receive oral placebo once daily for 12 months and placebo IV over
15 minutes on day 0 and at 6 months.

- Arm II: Participants receive oral letrozole once daily for 12 months and placebo IV
over 15 minutes on day 0 and at 6 months.

- Arm III: Participants receive oral letrozole once daily for 12 months and zoledronate
IV over 15 minutes on day 0 and at 6 months.

In all arms, treatment continues in the absence of unacceptable toxicity.

After completion of study treatment, participants are followed at 3 months.

PROJECTED ACCRUAL: A total of 120 participants (40 per treatment arm) will be accrued for
this study.