NCT00809484

Arimidex Bone Mass Index and Oral Bisphosphonates

A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 220 (actual)
• Sponsor: Hellenic Breast Surgeons Society · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer
• Bone Density

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2008-12-17
• Last updated: 2009-01-06

Locations

1 site across 1 country: Greece