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Sponsored by: |
International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00324714 |
RATIONALE: Bisphosphonates, such as risedronate, may help improve bone health and prevent osteoporosis in postmenopausal women. It is not yet known whether risedronate is effective in improving bone mineral density and bone health in women with ductal carcinoma in situ.
PURPOSE: This randomized phase III trial is studying risedronate to see how well it works compared to a placebo in improving bone mineral density and bone health in postmenopausal women with ductal carcinoma in situ enrolled in clinical trial CRUK-IBIS-II-DCIS.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition |
Drug: risedronate sodium Procedure: laboratory biomarker analysis |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind |
Official Title: | A Randomised, Double-Blind Trial to Assess the Effects on Bone Mineral Density and Bone Biomarkers of Anastrozole When Used to Prevent Breast Cancer in Postmenopausal Women |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, partially randomized, double-blind study. Patients are stratified according to bone mineral density (T-score) measurements (≥ -1.5 vs -2.5 to < -1.5 vs -4.0 to < -2.5 or ≤ 2 low-trauma vertebral fractures). Patients in stratum I are further stratified according to calcium and cholecalciferol (vitamin D) supplementation (yes vs no) and use of risedronate on this study (yes vs no). Patients in stratum II are further stratified according to randomized treatment on protocol CRUK-IBIS-II-DCIS (yes vs no).
Stratum II (T-score -2.5 to < -1.5 [moderate to severe osteopenia]): Patients undergo DXA scanning as in stratum I. Patients are also randomized (double-blind) to 1 of 2 treatment arms.
Blood samples for correlative studies (e.g., bone biomarkers, serum estradiol) are collected at baseline and at 6 and 12 months.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
Ages Eligible for Study: | 40 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ductal carcinoma in situ within the past 6 months
PATIENT CHARACTERISTICS:
No concurrent metabolic bone disease, including any of the following:
Hyperthyroidism or hypothyroidism
PRIOR CONCURRENT THERAPY:
More than 12 months since prior medication affecting bone metabolism, including any of the following:
Switzerland | |
Inselspital Bern | Recruiting |
Bern, Switzerland, CH-3010 | |
Contact: Manuela Rabaglio, MD 41-31-632-4370 manuela.rabaglio@insel.ch | |
Oncocare Sonnenhof-Klinik Engeriedspital | Recruiting |
Bern, Switzerland, CH-3012 | |
Contact: Katharina S. Buser, MD 41-31-309-9501 kbuser@sonnenhof.ch |
Principal Investigator: | Katharina S. Buser, MD | Oncocare Sonnenhof-Klinik Engeriedspital |
Study ID Numbers: | CDR0000474949, IBCSG-31-03-PBS, EUDRACT-2004-003991-12 |
Study First Received: | May 10, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00324714 |
Health Authority: | Unspecified |
osteoporosis ductal breast carcinoma in situ osteoporosis breast cancer in situ |
Anastrozole Skin Diseases Breast Neoplasms Osteoporosis Carcinoma Carcinoma, Ductal Calcium, Dietary |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Adenocarcinoma Breast Diseases Risedronic acid Neoplasms, Glandular and Epithelial |
Membrane Transport Modulators Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Physiological Effects of Drugs Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Neoplasms, Ductal, Lobular, and Medullary Pharmacologic Actions |