CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Calcitriol +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00904033
NCT00904033Phase 2Completed

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

University of Rochester·interventional·Posted May 19, 2009·Updated Apr 23, 2019

In Brief

A Phase 2 clinical trial evaluating Calcitriol, Exercise, and 1 other intervention for Breast Neoplasms and Bone and Bones. Completed, enrolled 41 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 19, 2009
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9.1 yearsPosted 17.1 years ago

Interventions

Calcitrioldrug

Calcitriol tablet taken once per week.

Exercisebehavioral

Exercise consisting of progressive walking and resistance band training

Multivitamindietary