CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 351 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01144468
NCT01144468N/ACompleted

Effects of Exemestane on Bone Strength in Postmenopausal Women at Increased Risk of Developing Breast Cancer

University Health Network, Toronto·observational·Posted Jun 15, 2010·Updated Mar 27, 2024

In Brief

An observational study for Osteoporosis and Breast Cancer. Completed, enrolled 351 participants across 4 sites in 2 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 15, 2010
Enrollment StartApr 1, 2007
Primary CompletionMay 1, 2013
Study CompletionJan 1, 2022
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 16.0 years ago