Status:
COMPLETED
Effects of Zometa and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-55 years
Phase:
PHASE3
Brief 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...
Detailed Description
Background: Breast cancer diagnosis accounts for 32% of all new cancer cases in US women, with approximately 211,300 women diagnosed in 2003. The majority of these women receive adjuvant chemotherapy,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00202059
Start Date
June 1 2003
End Date
September 1 2007
Last Update
December 16 2015
Active Locations (1)
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1
Park Nicollet Institute
Saint Louis Park, Minnesota, United States, 55416