Status:
COMPLETED
Effects of Exemestane on Bone Strength
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Canadian Breast Cancer Research Alliance
Conditions:
Osteoporosis
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The NCIC CTG was conducting an international breast cancer prevention trial (MAP.3) examining the effects of a new therapy (exemestane) for breast cancer prevention in postmenopausal women at increase...
Detailed Description
Aromatase inhibitors (AIs) substantially decrease estrogen levels in postmenopausal women; thus, they have the potential to prevent breast cancer, but they also have the potential to adversely affect ...
Eligibility Criteria
Inclusion
- Women participating in the MAP.3 clinical trial at centres with access to HR-pQCT
Exclusion
- Women with osteoporosis;
- Women with T-score of -2.0 or below at the lumbar spine (L1-L4), total hip or femoral neck;
- Women with a fragility fracture after age 40;
- Women who have been on any bone drug, such as hormone replacement therapy, selective estrogen receptor modulators, bisphosphonates, teriparatide, parathyroid hormone, sodium fluoride, strontium, calcitonin and high dose vitamin D (more than 2000iu of vitamin D3 daily),in the past 3 months;
- Women who have ever been on a bisphosphonate for more than 6 months;
- Women who have ever been on strontium for more than 1 month;
- Women who are on chronic oral steroids (the equivalent of 5mg of prednisone a day or higher for more than 2 weeks within the past 6 months and will likely require ongoing therapy);
- Women with Paget's disease, Cushing's disease, hyperparathyroidism, uncontrolled hyperthyroidism or other metabolic bone diseases;
- Women with decompensated diseases of the liver, bowel, kidney, pancreas, lung, or heart.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
351 Patients enrolled
Trial Details
Trial ID
NCT01144468
Start Date
April 1 2007
End Date
January 1 2022
Last Update
March 27 2024
Active Locations (4)
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1
University of California Davis
Sacramento, California, United States, 95817
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
University Health Network, TGH
Toronto, Ontario, Canada, M5G 2C4
4
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B6