- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00202059
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
연구 개요
상세 설명
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.
연구 유형
등록
단계
- 3단계
연락처 및 위치
연구 장소
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Minnesota
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St. Louis Park, Minnesota, 미국, 55416
- Park Nicollet Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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Change in Bone Mineral Density from baseline to 12 months after beginning chemotherapy
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2차 결과 측정
결과 측정 |
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삶의 질
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공동 작업자 및 조사자
수사관
- 수석 연구원: Karen K Swenson, RN, PhD, HealthPartners Institute
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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