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

December 15, 2015 updated by: HealthPartners Institute

The Effects of Zoledronic Acid (Zometa) and Physical Activity on Bone Density in Women Receiving Chemotherapy for Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in Bone Mineral Density from baseline to 12 months after beginning chemotherapy

Secondary Outcome Measures

Outcome Measure
Quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Karen K Swenson, RN, PhD, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

December 16, 2015

Last Update Submitted That Met QC Criteria

December 15, 2015

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1769-03-A
  • CZOL446E (Novartis)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Zoledronic acid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe