Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01144468
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2010-06-11
Brief Title:
Effects of Exemestane on Bone Strength
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Effects of Exemestane on Bone Strength in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAP3BSS
Brief Summary:
The NCIC CTG was conducting an international breast cancer prevention trial MAP3 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 Cheungs team followed the bone health of 354 women in MAP3 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
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 bone Previous animal data from our group suggests that exemestane a steroid AI may have a more favourable effect on bone metabolism than the non-steroidal AIs Over the past few years we have been conducting a 2-year companion study in a subset of women participating in the 5-year MAP3 trial-- a primary breast cancer prevention trial conducted by the NCIC Clinical Trials Group NCIC CTG to examine the effects of exemestane on the prevention of breast cancer This companion study is conducted at 3 geographic locations Toronto Canada Mayo Clinic in Rochester US and at the University of California Davis in California US in postmenopausal women who do not have osteoporosis at baseline to investigate the effects of exemestane on bone structure and density in the first 2 years of taking exemestane
On November 5 2010 the MAP3 study reached an early primary breast cancer event-driven endpoint Data analysis conducted March 2011 showed that after a median follow up of 35 months exemestane was superior to placebo in breast cancer prevention Based upon the positive results of the MAP3 trial and the relatively low incidence of adverse events seen in women receiving exemestane as compared to those receiving placebo the trial committee and NCIC CTG have agreed not to close the study Instead a modified observational study will continue We have also extended this 2-year study for another 3 years Recent data suggests that there is a difference in changes in BMD and perhaps fractures in women with breast cancer with the earlier effects 2 years being worse than the late effects As exemestane was found to be effective in the prevention of breast cancer it is likely going to be used for 5 years By extending this companion study for another 3 years we will be able to determine the long term up to 5 years effects of exemestane on bone structure and density and to compare the effects observed from 2 to 5 years of follow-up to those observed from baseline to 2 years
The primary objectives of our original 2-year study and this extension study are to determine whether exemestane will cause a clinically and statistically significant difference in percent change in total volumetric bone mineral density BMD at the distal radius as measured by high-resolution peripheral quantitative computed tomography HRpQCT from baseline to 2 years and from 2 to 5 years and 2 years post therapyas compared to placebo Our secondary objectives are 1 to determine the effects of exemestane on cortical and trabecular volumetric BMD as measured by pQCT scans at 1 2 3 and 5 years 2 to examine the effects of exemestane on other bone geometric parameters such as cortical thickness trabecular thickness trabecular separation and trabecular number at 1 2 3 and 5 years 3 to investigate the effect of exemestane on the percent change in BMD at the lumbar spine L1-L4 and the total hip as measured by dual energy X-ray absorptiometry DXA from baseline to 1 2 3 and 5 years as compared to placebo and 4 to determine the effect of 2 years of exemestane on bone strength index as compared to placebo We will also compare the early baseline to 2 years and late 2 to 5 years effects of exemestane on bone All participants in this companion study are provided with calcium and vitamin D supplementation Measurements of volumetric BMDs and bone geometric parameters are obtained by HRpQCT using Xtreme CT and measurements of areal BMDs are obtained by DXA using Hologic or Lunar densitometers at baseline 1 2 3 and 5 years according to standard protocols
The results of the proposed extension to the companion study will help us understand the long term effects and long term safety of exemestane on bone health in postmenopausal women at risk of developing breast cancer Data on healthy postmenopausal women taking long term 2-5 years exemestane does not exist at this time Information from this study will help clinicians and women weigh the risks and benefits of using exemestane and make informed decisions regarding breast cancer prevention
On November 5 2010 the MAP3 study reached an early primary breast cancer event-driven endpoint Data analysis conducted March 2011 showed that after a median follow up of 35 months exemestane was superior to placebo in breast cancer prevention Based upon the positive results of the MAP3 trial and the relatively low incidence of adverse events seen in women receiving exemestane as compared to those receiving placebo the trial committee and NCIC CTG have agreed not to close the study Instead a modified observational study will continue We have also extended this 2-year study for another 3 years Recent data suggests that there is a difference in changes in BMD and perhaps fractures in women with breast cancer with the earlier effects 2 years being worse than the late effects As exemestane was found to be effective in the prevention of breast cancer it is likely going to be used for 5 years By extending this companion study for another 3 years we will be able to determine the long term up to 5 years effects of exemestane on bone structure and density and to compare the effects observed from 2 to 5 years of follow-up to those observed from baseline to 2 years
The primary objectives of our original 2-year study and this extension study are to determine whether exemestane will cause a clinically and statistically significant difference in percent change in total volumetric bone mineral density BMD at the distal radius as measured by high-resolution peripheral quantitative computed tomography HRpQCT from baseline to 2 years and from 2 to 5 years and 2 years post therapyas compared to placebo Our secondary objectives are 1 to determine the effects of exemestane on cortical and trabecular volumetric BMD as measured by pQCT scans at 1 2 3 and 5 years 2 to examine the effects of exemestane on other bone geometric parameters such as cortical thickness trabecular thickness trabecular separation and trabecular number at 1 2 3 and 5 years 3 to investigate the effect of exemestane on the percent change in BMD at the lumbar spine L1-L4 and the total hip as measured by dual energy X-ray absorptiometry DXA from baseline to 1 2 3 and 5 years as compared to placebo and 4 to determine the effect of 2 years of exemestane on bone strength index as compared to placebo We will also compare the early baseline to 2 years and late 2 to 5 years effects of exemestane on bone All participants in this companion study are provided with calcium and vitamin D supplementation Measurements of volumetric BMDs and bone geometric parameters are obtained by HRpQCT using Xtreme CT and measurements of areal BMDs are obtained by DXA using Hologic or Lunar densitometers at baseline 1 2 3 and 5 years according to standard protocols
The results of the proposed extension to the companion study will help us understand the long term effects and long term safety of exemestane on bone health in postmenopausal women at risk of developing breast cancer Data on healthy postmenopausal women taking long term 2-5 years exemestane does not exist at this time Information from this study will help clinicians and women weigh the risks and benefits of using exemestane and make informed decisions regarding breast cancer prevention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None