The Effect of Bisphosphonate on Bone Mass and Bone Turnover in Elderly, Postmenopausal Women With Breast Cancer Following Initiation of Aromatase Inhibitor Therapy
This double-blind, placebo-controlled, randomized clinical trial will test the hypothesis
that risedronate 35 mg once weekly, a potent antiresorptive agent, will prevent bone loss or
improve bone mass and decrease bone turnover in elderly, osteopenic, postmenopausal women
(ages 55 and older) with breast cancer on aromatase inhibitor therapy. 110 subjects will be
randomized to receive either oral risedronate 35 mg once weekly or placebo for two years.
Our primary outcome variable will be change in PA spine bone mineral density (BMD).
Secondary endpoints will be BMD at the total hip, femoral neck, trochanter, lateral spine,
forearm, and total body, and markers of bone turnover. We will also assess if the
improvements in BMD are greater at sites of trabecular bone (spine) versus cortical bone
(wrist). BMD will be measured at six month intervals. Biochemical markers of bone turnover
will be measured at baseline, 6 months, 12 months, and 24 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
PA spine bone mineral density by DXA
at 6 month intervals over 2 years
Susan L. Greenspan, MD
University of Pittsburgh
United States: Food and Drug Administration
PRO06080002 (REBBeCA II)
|University of Pittsburgh Medical Center||Pittsburgh, Pennsylvania 15213|