Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3
- Conditions
- Breast CancerOsteoporosis
- Registration Number
- NCT00688246
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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).
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 238
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 2 years
- Secondary Outcome Measures
Name Time Method Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3 5 years Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3 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 2 years Number of clinical skeletal fractures by radiology report 2 years
Trial Locations
- Locations (18)
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
The Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Northeast Cancer Center Health Sciences
🇨🇦Sudbury, Ontario, Canada
Hutzel Women's Health Specialists
🇺🇸Detroit, Michigan, United States
Suburban Hospital Cancer Program
🇺🇸Bethesda, Maryland, United States
Los Angeles Biomedical Research Institute
🇺🇸Torrance, California, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Univ. of Wisconsin Center for Women's Health and
🇺🇸Madison, Wisconsin, United States
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
The George Washington University
🇺🇸Washington, District of Columbia, United States