Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

National Cancer Institute (NCI)

North Central Cancer Treatment Group

Conditions:

Breast Cancer

Osteoporosis

Eligibility:

FEMALE

45-120 years

Phase:

PHASE3

Brief 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...

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 os...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Enrolled in and meets eligibility requirements for protocol CAN-NCIC-MA27
  • Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L1-L4 postero-anterior spine and hip within 12 weeks prior to randomization on protocol CAN-NCIC-MA27
  • Hormone receptor status:
  • Estrogen receptor- and/or progesterone receptor-positive tumor
  • PATIENT CHARACTERISTICS:
  • Female
  • Postmenopausal
  • No malabsorption syndrome
  • No known cholecalciferol (vitamin D) deficiency, active hyper- or hypoparathyroidism, or Paget's disease
  • No uncontrolled thyroid disease, Cushing's disease, or other pituitary disease
  • No other bone disease (including osteomalacia or osteogenesis imperfecta)
  • PRIOR CONCURRENT THERAPY:
  • More than 6 months since prior drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (stratum I)
  • More than 12 months since prior and no concurrent anticonvulsants
  • More than 6 months since prior and no concurrent corticosteroids at doses \> 5 mg/day of prednisone (or equivalent) for \> 2 weeks
  • More than 12 months since prior and no concurrent anabolic steroids
  • No prior bisphosphonates (stratum II)
  • No concurrent sodium fluoride at daily doses ≥ 5 mg/day
  • No long-term (i.e., \> 6 months) use of coumarins
  • No concurrent drugs (investigational or not), including bisphosphonates, for the prevention of osteoporosis (for patients with no osteopenia or osteoporosis \[stratum I\])

Exclusion

    Key Trial Info

    Start Date :

    April 24 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 6 2012

    Estimated Enrollment :

    497 Patients enrolled

    Trial Details

    Trial ID

    NCT00354302

    Start Date

    April 24 2006

    End Date

    January 6 2012

    Last Update

    April 2 2020

    Active Locations (13)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (13 locations)

    1

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    2

    CancerCare Manitoba

    Winnipeg, Manitoba, Canada, R3E 0V9

    3

    The Moncton Hospital

    Moncton, New Brunswick, Canada, E1C 6Z8

    4

    Atlantic Health Sciences Corporation

    Saint John, New Brunswick, Canada, E2L 4L2