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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00202059
First received: September 13, 2005
Last updated: September 16, 2009
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Zoledronic acid
Behavioral: Physical activity intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Zoledronic Acid (Zometa) and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Change in Bone Mineral Density from baseline to 12 months after beginning chemotherapy

Secondary Outcome Measures:
  • Quality of life

Estimated Enrollment: 72
Study Start Date: June 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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, which may lead to chemotherapy-induced menopause (CIM) in premenopausal women. CIM often leads to accelerated bone loss, osteopenia, and eventual osteoporosis.

Purpose: 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. Secondary objectives are to compare the percent change between the groups in total hip BMD, the incidence of vertebral fractures, fatigue, functional status, and other cancer-related symptoms between the two groups.

Methods: Seventy-two women will be enrolled and randomized to one of two treatment groups. For participants randomized to Group A, intravenous zoledronic acid will be given every 3 months for the 12 month study period, along with 2 tablets of calcium carbonate (600 mg)/vitamin D (200 IU) daily. For participants randomized to Group B, a physical activity intervention designed to improve BMD will be prescribed and administered through the occupational rehabilitation department. Group B participants will also take 2 tablets of calcium carbonate (600 mg)/vitamin D (200 IU) daily. BMD measurements at the lumbar spine and hip, and an AP and lateral X-ray will be done at baseline and at 12 months after enrollment in the study, using dual energy X-ray absorptiometry (DXA). Serum bone-specific alkaline phosphotase, and N-telopeptide urine tests will be conducted at baseline and 12 months to evaluate bone resorption activity. Other measures that will be assessed via questionnaires include fatigue (Schwartz Cancer Fatigue Scale), functional status (SF-36), a 4-day food record, and other cancer-related symptoms (MD Anderson Symptom Inventory).

Analysis: Results will be analyzed on an intent-to-treat basis. Descriptive statistics will be used to analyze demographic data, tumor information, dietary information and baseline BMD. Differences between baseline means will be analyzed by t-tests. The percent change in BMD between the two groups will be analyzed by analysis of covariance (ANCOVA). Differences in other measures will be analyzed by t-tests.

Results: Results of this study will be used to determine if zoledronic acid or physical activity affect BMD in young women who are receiving chemotherapy for breast cancer.

  Eligibility

Ages Eligible for Study:   40 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202059

Locations
United States, Minnesota
Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Novartis Pharmaceuticals
Investigators
Principal Investigator: Karen K Swenson, RN, PhD Park Nicollet Institute
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00202059     History of Changes
Other Study ID Numbers: 1769-03-A, CZOL446E
Study First Received: September 13, 2005
Last Updated: September 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Breast cancer
Bone mineral density
Chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014