Anastrozole Biphosphonate Study in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer - SABRE

Study identifier:D5392C00050

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Breast Cancer

Phase

Phase 4

Healthy volunteers

No

Study drug

Anastrozole, Risedronate Sodium

Sex

Female

Actual Enrollment

237

Study type

Interventional

Age

55 Years +

Date

Study Start Date: 01 Apr 2004
Primary Completion Date: 01 Oct 2007
Study Completion Date: 01 Oct 2007

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria