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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00082277

Acronym

SABRE

Enrollment

237

Registered

2004-05-06

Start date

2004-04-30

Completion date

2007-10-31

Last updated

2011-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

hormone-receptor positive, breast cancer, Osteopenia, Osteoporosis, risk of fracture, bone loss

Brief summary

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Interventions

DRUGAnastrozole

1mg/Day Oral

DRUGRisedronate Sodium

35mg/week, oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)	Assessed at 12 months

Secondary

Measure	Time frame
Change from baseline in lumbar spine (L1-L4) BMD	Assessed at 24 months
Change from baseline in bone formation markers	Assessed at 6 and12 months
Change from baseline in total hip BMD	Assessed at 12 and 24 months
Change from baseline in LDL-cholesterol	Assessed at 12 months
Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides	Assessed at 3, 6 and 12 months
Change from baseline in bone resorption and formation markers	Assessed at 6 and 12 months

Countries

Canada, France, Greece, Netherlands, South Africa, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026