Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer And Who Are Receiving Exemestane on Clinical Trial CAN-NCIC-MAP3
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00688246|
Recruitment Status : Completed
First Posted : June 2, 2008
Last Update Posted : November 13, 2013
RATIONALE: Learning about the effect of exemestane on bone mineral density in postmenopausal women at increased risk of breast cancer may help plan treatment, decrease the risk of broken bones, and help patients live more comfortably.
PURPOSE: This research study is measuring bone mineral density in postmenopausal women at increased risk of developing breast cancer who are receiving exemestane on clinical trial CAN-NCIC-MAP3.
|Condition or disease||Intervention/treatment|
|Breast Cancer Osteoporosis||Other: biologic sample preservation procedure Procedure: dual x-ray absorptometry|
- To assess the percentage change in bone mineral density (BMD) as measured by dual x-ray absorptometry (DEXA) scans of the spine (L1-L4) and total hip 2 years after randomization (and registration to the MAP.3B protocol).
- To assess the percentage change in BMD as measured by DEXA scans of the spine (L1-L4), and total hip 5 years after randomization (and registration to the MAP.3B protocol).
- To compare the proportion of women who develop BMD of the spine (L1-L4) and total hip below the absolute threshold value for osteoporosis (T score ≤ -2.5 SD below the mean peak bone mass in young women) in the treatment groups.
- To examine the pattern of changes in BMD parameters and bone biomarkers (i.e., PINP and NTx) over time and the impact of covariants using exploratory longitudinal analyses.
- To compare the proportion of women who develop clinical skeletal fractures in the treatment groups.
OUTLINE: Patients undergo bone mineral density (BMD) measurement by dual x-ray absorptometry (DEXA). Blood specimens are collected at baseline and at 1 year, and 5 years and stored in a central laboratory for future assays of the bone biomarkers.
If the subject withdraws from the core MAP.3 study before 5 years, a bone density measurement and serum for bone biomarkers is obtained unless performed within the past 3 months. Patients may continue to be followed on the MAP.3 core study for fractures (and other MAP.3 study endpoints) for a minimum of 5 years after randomization.
|Study Type :||Observational|
|Actual Enrollment :||238 participants|
|Official Title:||The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||January 2013|
Other: biologic sample preservation procedure
- Change in bone mineral density (BMD) as measured by dual x-ray absorptometry (DEXA) scans of the spine (L1-L4) and total hip 2 years after randomization [ Time Frame: 2 years ]
- Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3 [ Time Frame: 5 years ]
- Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3 [ Time Frame: 5 years ]
- Development of osteoporosis either by sustaining a fragility fracture or by having a BMD T-score at or lower than - 2.5 SD at the spine (L1-L4) or total hip [ Time Frame: 2 years ]
- Number of clinical skeletal fractures by radiology report [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688246
|United States, California|
|Los Angeles Biomedical Research Institute|
|Torrance, California, United States, 90502|
|United States, District of Columbia|
|The George Washington University|
|Washington, District of Columbia, United States, 20037|
|United States, Maine|
|Maine Center for Cancer Medicine and Blood Disorders|
|Scarborough, Maine, United States, 04074-9308|
|United States, Maryland|
|Suburban Hospital Cancer Program|
|Bethesda, Maryland, United States, 20817|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Hutzel Women's Health Specialists|
|Detroit, Michigan, United States, 48201|
|United States, New Jersey|
|University of Medicine and Dentistry of New Jersey|
|Newark, New Jersey, United States, 07107|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Rhode Island|
|The Memorial Hospital of Rhode Island|
|Pawtucket, Rhode Island, United States, 02860|
|United States, Vermont|
|Fletcher Allen Health Care|
|Burlington, Vermont, United States, 05401|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|United States, Wisconsin|
|Univ. of Wisconsin Center for Women's Health and|
|Madison, Wisconsin, United States, 53715|
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Northeast Cancer Center Health Sciences|
|Sudbury, Ontario, Canada, P3E 5J1|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Paul E. Goss, MD, PhD||Massachusetts General Hospital|