drugset / Trial / NCT00202059

Effects of Zometa and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer

NCT00202059 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the effect of zoledronic acid and physical activity on preventing bone loss in women aged 40 - 55 who are receiving chemotherapy for breast cancer. The primary objective is to compare the percent change in the lumbar spine bone mineral density (BMD) from baseline to 12 months for women who are randomized to either: Group A) intravenous zoledronic acid, oral calcium carbonate, and vitamin D, or Group B) a prescribed physical activity program, oral calcium carbonate and vitamin D.

Timeline

Start
2003-06
Primary completion
2007-09
Completion
2007-09

Outcome

Met primary endpoint

paper Although spine, total hip, and total body BMD increased in the ZO group by 1.6%, 0.8%, and 0.8%, respectively PMID 19507458 ↗

paper BMD decreased in the PA group by 6.0%, 3.4%, and 3.3%, respectively (P values < 0.0001 for all group comparisons). PMID 19507458 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Zoledronic acid Other / unclassified — Intravenous