Effects of Zometa and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer
The Effects of Zoledronic Acid (Zometa) and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer
2 other identifiers
interventional
72
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 breast-cancer
Started Jun 2003
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedDecember 16, 2015
April 1, 2007
4.3 years
September 13, 2005
December 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Bone Mineral Density from baseline to 12 months after beginning chemotherapy
Secondary Outcomes (1)
Quality of life
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HealthPartners Institutelead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
Park Nicollet Institute
Saint Louis Park, Minnesota, 55416, United States
Related Publications (2)
Swenson KK, Nissen MJ, Anderson E, Shapiro A, Schousboe J, Leach J. Effects of exercise vs bisphosphonates on bone mineral density in breast cancer patients receiving chemotherapy. J Support Oncol. 2009 May-Jun;7(3):101-7.
PMID: 19507458RESULTAdams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen K Swenson, RN, PhD
HealthPartners Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
June 1, 2003
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
December 16, 2015
Record last verified: 2007-04