NCT00354302

Bone Mineral Density in Postmenopausal Women With Primary Breast Cancer Who Are Receiving Treatment on Clinical Trial

The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density In Postmenopausal Women With Primary Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 497 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Female
• Age: 45 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Learning about the effect of exemestane and anastrozole on bone mineral density in postmenopausal women with primary breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably. PURPOSE: This phase III trial is studying bone mineral density in postmenopausal women with primary breast cancer who are receiving treatment on clinical trial CAN-NCIC-MA27.

Detailed description

OBJECTIVES: * Determine whether there is a clinically relevant difference in bone mineral density (BMD) at 2 years in postmenopausal women with primary breast cancer (with or without osteopenia or osteoporosis) treated with exemestane vs anastrozole on protocol CAN-NCIC-MA27. OUTLINE: This is a multicenter, companion study. Patients are stratified according to baseline bone mineral density (BMD) measurement (T-score\* ≥ -2.0 standard deviation \[SD\] \[no osteopenia or osteoporosis\] vs T-score\* \< -2.0 SD). NOTE: \*The lowest of the two T-scores: L1-L4 or total hip Blood samples for the identification of bone biomarkers (formation marker: serum amino-terminal procollagen 1 extension peptide \[P1NP\] and resorption marker: serum N-telopeptide) are obtained at baseline and at 6 and 12 months. BMD is determined by dual-energy x-ray absorptiometry (DEXA) at baseline and then annually for 5 years (or for as long as patient is receiving treatment on protocol CAN-NCIC-MA27). Patients receive oral calcium and oral cholecalciferol (vitamin D) daily. Patients with osteopenia or osteoporosis (stratum II) also receive oral bisphosphonate therapy PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.

Conditions

• Breast Cancer
• Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	calcium carbonate
DIETARY_SUPPLEMENT	calcium citrate
DIETARY_SUPPLEMENT	cholecalciferol
DRUG	alendronate sodium
DRUG	calcium gluconate
DRUG	risedronate sodium
OTHER	laboratory biomarker analysis
PROCEDURE	dual x-ray absorptometry

Timeline

• Start date: 2006-04-24
• Primary completion: 2011-03-01
• Completion: 2012-01-06
• First posted: 2006-07-20
• Last updated: 2020-04-02

Locations

13 sites across 1 country: Canada