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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


Phase 4
55 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


Inclusion Criteria:



- Women defined as Postmenopausal

- Histologically proven operable invasive breast cancer

- Hormone-receptor-positive breast cancer

Exclusion Criteria:

- Clinical evidence of metastatic disease

- Bilateral hip fractures or bilateral hip prosthesis

- Receiving or received in last 12 months hormonal therapy for breast cancer,
bisphosphonate therapy, oestrogens

- Malabsorption syndrome

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

Name

Location
Research Site Anaheim, California  
Research Site Boca Raton, Florida  
Research Site Baton Rouge, Louisiana  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Allentown, Pennsylvania  
Research Site Abilene, Texas