Arimidex Bone Mass Index and Oral Bisphosphonates (ARBI)

Hellenic Breast Surgeons Society

Status: Completed

Conditions: Breast Cancer; Bone Density

Study type: Observational

Funder types: Other

Identifiers

NCT00809484

D5392L0027

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women
• ER and or PgR positive breast cancer
• Completed Surgery and =/- chemotherapy

Exclusion criteria

• metastases
• history of fractures
• HRT or SERMs
• Liver or kidney disfunction

Trial design

220 participants in 3 patient groups

1: Low risk

Description:

Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily

2:Moderate risk

Description:

Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, +/- Risedronate 35mg orally once a week

3:High risk

Description:

Anastrozole 1mg/d, Vit D 400 IU and 500mg Calcium daily, Risedronate 35mg orally once a week