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| Sponsored by: |
Hellenic Breast Surgeons Society |
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| Information provided by: | Hellenic Breast Surgeons Society |
| ClinicalTrials.gov Identifier: | NCT00809484 |
Purpose
To investigate the management of bone health in postmenopausal women with early breast cancer (BCA) scheduled to receive anastrozole. Postmenopausal women with hormone receptor-positive early BCA are assigned to 1 of 3 strata depending on their pre-existing risk of fragility fracture. Patients (pts) with a bone mineral density (BMD) T-score <-2.0 for either spine or hip are designated higher-risk (H) for fracture and receive anastrozole 1 mg/day plus risedronate orally. Moderate-risk (M) pts (T-score <-1.0 for spine or hip but -2.0 at both sites) are randomized to receive anastrozole plus risedronate (A+R) or anastrozole alone. Pts with T-scores -1.0 at both spine and hip were designated lower-risk (L) and receive anastrozole alone. All pts receive calcium and vitamin D. Lumbar spine and total hip BMD are assessed at baseline, 12, and 24 months.
| Condition |
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Breast Cancer Bone Density |
| Study Type: | Observational |
| Study Design: | Case-Only, Prospective |
| Official Title: | A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer. |
| Enrollment: | 220 |
| Study Start Date: | May 2004 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1: Low risk
Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily
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2:Moderate risk
Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, +/- Risedronate 35mg orally once a week
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3:High risk
Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, Risedronate 35mg orally once a week
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Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Posmenopusal women with endocrine responsive breast cancer who are treated with the aromatase inhibitor anastrozole
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Hellenic Breast Surgeons Society ( Markopoulos Christos ) |
| Study ID Numbers: | D5392L0027 |
| Study First Received: | December 16, 2008 |
| Last Updated: | January 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00809484 |
| Health Authority: | Greece: National Organization of Medicines |
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Arimidex Bone Mineral density Bisphosphonates Aromatase Inhibitors |
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Anastrozole Diphosphonates Skin Diseases Breast Neoplasms Breast Diseases |
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Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Enzyme Inhibitors Bone Density Conservation Agents Aromatase Inhibitors Pharmacologic Actions |
