The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer
- 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
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.
Observational Model: Cohort, Time Perspective: Prospective
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
Paul E. Goss, MD, PhD
Massachusetts General Hospital
Canada: Health Canada
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Fletcher Allen Health Care||Burlington, Vermont 05401|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|University of Medicine and Dentistry of New Jersey||Newark, New Jersey 07103-2425|
|Maine Center for Cancer Medicine and Blood Disorders||Scarborough, Maine 04074|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of Oklahoma||Oklahoma City, Oklahoma 73190|
|Suburban Hospital Cancer Program||Bethesda, Maryland 20817|
|Los Angeles Biomedical Research Institute||Torrance, California 90502|
|The George Washington University||Washington, District of Columbia 20037|
|Hutzel Women's Health Specialists||Detroit, Michigan 48201|
|The Memorial Hospital of Rhode Island||Pawtucket, Rhode Island 02860|
|Univ. of Wisconsin Center for Women's Health and||Madison, Wisconsin 53715|