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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthPartners Institute
• Collaborator: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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