NCT00904033

Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

A Pilot Study of the Effects of High-Dose Oral Calcitriol and Physical Activity on Bone Health in Breast Cancer Survivors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Both the calcitriol and exercise interventions are aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients and survivors. The combination of calcitriol and exercise, which function through different but similar mechanisms, could produce interactive effects in reducing fracture risk among breast cancer survivors. Hypothesis: A combination of calcitriol along with a structured home-based walking and progressive resistance exercise program will be efficacious in preventing bone resorption and in increasing bone formation among survivors of invasive breast cancer.

Detailed description

Primary Objective To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving bone health among breast cancer survivors. Secondary Objectives To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for increasing strength among breast cancer survivors. To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving skeletal muscle mass among breast cancer survivors.

Conditions

• Breast Neoplasms
• Bone and Bones

Interventions

Type	Name	Description
DRUG	Calcitriol	Calcitriol tablet taken once per week.
BEHAVIORAL	Exercise	Exercise consisting of progressive walking and resistance band training
DIETARY_SUPPLEMENT	Multivitamin

Timeline

• Start date: 2008-12-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2009-05-19
• Last updated: 2019-04-23
• Results posted: 2019-04-23

Locations

1 site across 1 country: United States