The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer
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.
Observational
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
2 years
No
Paul E. Goss, MD, PhD
Study Chair
Massachusetts General Hospital
Canada: Health Canada
MAP3B
NCT00688246
January 2008
January 2013
Name | Location |
---|---|
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 |