A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery
The calcitriol intervention is aimed at reducing fracture risk by maintaining proper bone
density. Calcitriol is efficacious in maintaining proper bone health and muscle mass among
the general population, but little research has been done on breast cancer patients. In
addition, calcitriol may be effective in reducing tumor proliferation and angiogenesis,
while increasing tumor apoptosis. Each of those factors could have beneficial effects on
breast cancer outcomes.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
efficacy and feasibility of Calcitriol 45 μg
To collect data on the efficacy and feasibility of Calcitriol 45 μg for maintaining proper bone health among invasive breast cancer patients for a period of 12 weeks. To collect preliminary data on the effect of Calcitriol 45 μg on bone resorption, as measured by Cross-Linked N-Telopeptide of Type I collagen (NTx) in invasive breast cancer patients over the course of 12 weeks. To collect preliminary data on the effect of Calcitriol 45 μg on markers of bone formation, as measured by bone-specific alkaline phosphatase (BAP) in invasive breast cancer patients over the course of 12 weeks.
Luke J Peppone, PhD
University of Rochester
United States: Institutional Review Board
|University of Rochester||Rochester, New York 14642|