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

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00202059

Run by

HealthPartners Institute

People needed

72

Starts

2003-06-01

Expected to finish

2007-09-01

Last updated by the study team

2015-12-16

Who can join

Age: 40 and older, up to 55. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with Stage I - II breast cancer
• Ages 40 - 55
• Pre- or peri-menopausal
• Within 1 month of beginning adjuvant or neoadjuvant chemotherapy
• Baseline lumbar spine and total hip BMD > -2.0 SD
• Able to read and write English
• Signed consent form

You may not qualify if…

• Previous treatment with bisphosphonates
• Laboratory evidence of renal disease
• Previous TRAM flap reconstructive surgery
• Positive pregnancy test
• Mental illness that precludes the patient from giving informed consent
• Laboratory evidence of hepatic disease

Where it is running

• Park Nicollet Institute — Saint Louis Park, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.