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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: Anastrozole
    • 1mg/Day Oral
  • Drug: Risedronate Sodium
    • 35mg/week, oral

Arms, Groups and Cohorts

  • Experimental: 1
    • High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
  • Experimental: 2
    • Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
  • Experimental: 3
    • Low-Risk of Fragility Fracture – Open-Label, Non-Comparative Stratum

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Francisco Sapunar, MD – Arimidex Medical Science Director, AstraZeneca
  • Overall Official(s)
    • AstraZeneca Arimidex Medical Science Director, MD, Study Director, AstraZeneca

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