NCT01293682

Effects of High Dose Calcitriol in Breast Cancer Patients

A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years – 88 Years
• Healthy volunteers: Not accepted

Summary

This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Calcitriol	In pill form, 45 micrograms once a week for 12 weeks

Timeline

• Start date: 2010-11-01
• Primary completion: 2018-08-01
• Completion: 2021-12-01
• First posted: 2011-02-10
• Last updated: 2022-04-20
• Results posted: 2020-02-07

Locations

1 site across 1 country: United States