Maintaining Skeletal Health in Postmenopausal Women With Surgically Resected Stage I-IIIa Hormone-receptor Positive Breast Cancer Who Are Receiving Anastrozole, Through the Use of Alendronate as Determined by the Osteoporosis Australia Bone Maintenance Algorithm

Barwon Health8 sites in 1 country303 target enrollmentSeptember 2005

ConditionsBreast Cancer

InterventionsAlendronate sodium

DrugsAlendronate sodium

Overview

Phase: Phase 3
Intervention: Alendronate sodium
Conditions: Breast Cancer
Sponsor: Barwon Health
Enrollment: 303
Locations: 8
Primary Endpoint: Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the use of an oral bisphosphonate (alendronate) in preventing bone loss in postmenopausal women with early breast cancer who are receiving anastrozole therapy, and to determine how long alendronate treatment is needed.

Registry

clinicaltrials.gov

Start Date

September 2005

End Date

March 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Barwon Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Postmenopausal
•Adequately diagnosed and treated Stage I-IIIa early breast cancer
•Oestrogen receptor and/or progesterone receptor positive breast cancer
•Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
•Hormone replacement therapy (HRT) must be discontinued at least 2 weeks prior to registration
•Any prior tamoxifen taken for a total of 8 weeks or less
•Any prior anastrozole taken for a total of 4 weeks or less
•Anastrozole is clinically indicated to be the best adjuvant strategy
•Signed written informed consent

Exclusion Criteria

•Clinical or radiological evidence of distant spread of disease
•Prior treatment with bisphosphonates within the past 12 months
•Prior treatment with continuous systemic corticosteroids within the past 12 months
•Prior use of parathyroid hormone for more than 1 week
•Prior use of systemic sodium fluoride for \> 3 months during the past 2 years
•Currently treated with any drugs known to affect the skeleton
•Abnormal renal function (serum creatinine greater than or equal to 265.2 mmol/L)
•History of diseases with influence on bone metabolism. Patients with lactose intolerance are also excluded
•Delayed oesophageal emptying such as stricture or achalasia
•Hypersensitivity to alendronate or anastrozole

Arms & Interventions

Anastrozole and alendronate

Patients will receive anastrozole for 5 years and alendronate for 3 years or anastrozole and alendronate treatment for 5 years.

Intervention: Alendronate sodium

Outcomes

Primary Outcomes

Changes in lumbar vertebra and femoral neck bone mineral density (BMD) T-score after 5 years of anastrozole treatment

Time Frame: 5 years

Secondary Outcomes

Percent change in the lumbar vertebra (L2 to L4) and femoral neck BMD(12 monthly intervals)
Biochemical markers of bone turnover (N-telopeptide and bone-specific alkaline phosphatase) and BMD(6 months after registration and/or 6 months after commencing alendronate)
Evaluate the Osteoporosis Australia strategy for bone protection for this patient group(5 years)
Evaluate the clinical fracture incidence cumulative over 5 years(5 years)
Perform an economic analysis of the cost of monitoring and intervention(5 years)
Evaluate the time to disease recurrence/relapse in women treated with anastrozole as adjuvant therapy(5 years)
Evaluate the effects of anastrozole on serum lipid parameters following 6 months therapy(6 months)