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

Phase 4

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Risedronate Sodium

• Registration Number: NCT00082277
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-05-05
• Study First Submitted QC: 2004-05-05
• Study First Posted: 2004-05-06
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 237

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Risedronate Sodium	High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
2	Risedronate Sodium	Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
3	Anastrozole	Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
1	Anastrozole	High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
2	Anastrozole	Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
3	Risedronate Sodium	Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in total hip BMD	Assessed at 12 and 24 months
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 bone resorption and formation markers	Assessed at 6 and 12 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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Luton, United Kingdom