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	Treatment or Intervention	Phase
Breast Cancer	Drug: risedronate sodium (ACTONEL TM) 35 mg per week, oral	Phase III

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

AstraZeneca Cancer Support Network      (866) 992-9276 

California
      Research Site, Palm Springs,  California,  United States; Recruiting
Florida
      Research Site, Orlando,  Florida,  United States; Recruiting
      Research Site, Jacksonville,  Florida,  United States; Recruiting
Louisiana
      Research Site, New Orleans,  Louisiana,  United States; Recruiting
New York
      Research Site, New York,  New York,  United States; Recruiting
North Carolina
      Research Site, Raleigh,  North Carolina,  United States; Recruiting
Ohio
      Research Site, Cleveland,  Ohio,  United States; Recruiting
Pennsylvania
      Research Site, Pittsburgh,  Pennsylvania,  United States; Recruiting
Texas
      Research Site, Houston,  Texas,  United States; Recruiting

Study ID Numbers:  D5392C00050
Record last reviewed:  November 2004
Last Updated:  November 9, 2004
Record first received:  May 5, 2004
ClinicalTrials.gov Identifier:  NCT00082277
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08