A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)

Outcome Time Frame:

Assessed at 12 months

Safety Issue:

No

Principal Investigator

AstraZeneca Arimidex Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D5392C00050

NCT ID:

NCT00082277

Start Date:

April 2004

Completion Date:

October 2007

Related Keywords:

• Breast Cancer
• hormone-receptor positive, breast cancer
• Osteopenia
• Osteoporosis
• risk of fracture
• bone loss
• Breast Neoplasms