Arimidex Bone Mass Index and Oral Bisphosphonates

Breast Cancer Clinical Trial

— ARBI  

Official title:

A Phase III-IV, Multicenter Open Label Trial of Arimidex Alone Versus Arimidex Plus Bisphosphonates in Postmenopausal Patients With Early, Endocrine Positive Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00809484
• Other study ID #: D5392L0027
• Status: Completed
• Phase: N/A
• First received: December 16, 2008
• Last updated: January 3, 2009
• Start date: May 2004
• Est. completion date: February 2007

Study information

• Verified date: December 2008
• Source: Hellenic Breast Surgeons Society
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Density
• Breast Cancer

Locations

Country	Name	City	State
Greece	Hellenic Breast Surgeons Society	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Breast Surgeons Society

Country where clinical trial is conducted

Greece,