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NCT01144468 · ClinicalTrials.gov registry record
Effects of Exemestane on Bone Strength
A clinical trial, sponsored by University Health Network, Toronto.
- Completed
- Registry status
- 351
- Enrollment target
NCT01144468: Completed study, sponsored by University Health Network, Toronto.
NCT01144468 is a clinical trial that has completed, run by University Health Network, Toronto. The registered enrollment target is 351 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01144468 has completed, sponsored by University Health Network, Toronto.
- COMPLETED
- Registry status
- 351 participants
- Enrollment target
Study 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 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.
Primary Outcome
Mean percent change in total volumetric bone mineral density (BMD) measured by high resolution peripheral quantitative computer tomography )HR-pQCT from baseline to 24 months
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 351 participants |
| Start Date | 2007-04 |
| Est. Completion | 2022-01 |
What the finished NCT01144468 record still lists
NCT01144468 is an observational study that tracks outcomes without assigning an intervention. The registered 351 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01144468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01144468 about?
NCT01144468 is a clinical study titled "Effects of Exemestane on Bone Strength". 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, exemes...
What is the current status of trial NCT01144468?
This trial is currently completed. The enrollment target is 351 participants. The study started on 2007-04. Estimated completion is 2022-01.
Who is sponsoring clinical trial NCT01144468?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
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