Risedronate Sodium on Bone in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.Condition:- Breast CancerStudy Type: InterventionalStudy Design: Treatment Official Title: A Multicenter Phase III/IV Study of the Effects of Risedronate Sodium on Bone in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer, Treated with Anastrozole and Stratified by Fragility Risk Eligibility Genders Eligible for Study: Female Criteria Inclusion Criteria:Postmenopausal women with histological proven operable invasive breast cancer and hormone-receptor positive breast tumor are included patient has completed all primary surgery and chemotherapy and is a candidate to receive hormonal adjuvant therapy Exclusion Criteria:clinical evidence of metastatic disease has had bilateral hip fractures or bilateral hip prosthesis has had fracture of any kind, or orthopedic surgery, within the previous 6 months has received excluded medications within previous 12 months has malabsorption syndrome, various endocrine disorders or abnormalities of the esophagus which delay esophageal emptying are unable to sit up or stand upright for a least 30 minutes, known hypersensitivity to any component of anastrozole or risedronate, has had treatment with a non-approved drug in the previous 3 months are at risk of transmitting HIV or hepatitis B via infected blood hypocalcemia or hypercalcemia, low serum phosphate levels, liver enzymes > 3x upper normal limit, clinically significant renal impairment [1] AstraZeneca