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Completed

NCT Number: NCT00082277

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

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.

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Key information

Conditions

Breast Cancer Bone Diseases Bone Diseases, Metabolic Breast Diseases Breast Neoplasms Metabolic Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Osteoporosis Skin Diseases Skin and Connective Tissue Diseases

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Burnaby, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

1mg/Day Oral

Other names: ARIMIDEX™, ZD1033

risedronate sodium

Drug

35mg/week, oral

Other names: ACTONEL™

Primary outcomes

  1. The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)

    Time frame: Assessed at 12 months

Secondary outcomes

  1. Change from baseline in total hip BMD

    Time frame: Assessed at 12 and 24 months

  2. Change from baseline in lumbar spine (L1-L4) BMD

    Time frame: Assessed at 24 months

  3. Change from baseline in bone formation markers

    Time frame: Assessed at 6 and12 months

  4. Change from baseline in bone resorption and formation markers

    Time frame: Assessed at 6 and 12 months

  5. Change from baseline in LDL-cholesterol

    Time frame: Assessed at 12 months

  6. Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides

    Time frame: Assessed at 3, 6 and 12 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: SABRE

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
May 6, 2004
Registry last updated
Jan 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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