Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Virginia
With
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Accepted
