Effects of Exemestane on Bone Strength
Completed
Conditions studied: Osteoporosis, Breast Cancer
In brief
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 increased risk of developing this disease. Results showed that after a median follow up of 35 months, exemestane was superior to placebo in breast cancer prevention. Exemestane blocks estrogen production, which may be beneficial for preventing breast cancer, but may have negative effects on bone. As postmenopausal women are at risk for developing osteoporosis, determining whether exemestane causes bones to weaken is crucial for women considering it for long-term use. Dr. Cheung's team followed the bone health of 354 women in MAP.3 in detail over 2 years and found that volumetric bone mineral density (by high resolution peripheral quantitative computer tomography (HR-pQCT) at the radius and tibia as well as areal bone mineral density by dual energy x-ray absorptiometry (DXA) at the hip and spine decreased significantly with the use of exemestane. The long term effects of exemestane on bone will be examined up to 5 years of therapy and then 2 years post therapy to delineate the effects of exemestane on bone strength. This research will inform us on the safety of exemestane for breast cancer prevention.
Key facts
- Study ID
- NCT01144468
- Run by
- University Health Network, Toronto
- People needed
- 351
- Starts
- 2007-04-01
- Expected to finish
- 2022-01-01
- Last updated by the study team
- 2024-03-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Women participating in the MAP.3 clinical trial at centres with access to HR-pQCT
You may not qualify if…
- 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.
Where it is running
- University of California Davis — Sacramento, California, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University Health Network, TGH — Toronto, Ontario, Canada
- Women's College Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.