238
Participants
Start Date
July 10, 2008
Primary Completion Date
October 31, 2011
Study Completion Date
January 10, 2013
biologic sample preservation procedure
Increased bone turnover may be a risk factor for fracture \[Lønning 2005\]. However, it is uncertain whether markers of bone resorption and markers of bone formation are both associated with fracture risk \[Looker 2000\]. Therefore, we will measure bone formation and bone resorption markers at baseline, year 1 and year 5. Blood specimens will be shipped to and stored in a central laboratory for future assays of bone biomarkers. For markers of bone formation, the N-terminal Propeptide of Type I Collagen (PINP) will be measured. For bone resorption markers, serum levels of cross-linked N-telopeptides of type I collagen (NTx) will be measured. Note: Subjects must fast 12-14 hours prior to blood draw.
dual x-ray absorptometry
BMD of the spine (L1-L4) and total hip will be done within 12 months prior to randomization to the MAP.3 core protocol. BMD by DEXA of the spine (L1-L4) and total hip will be repeated at year 2 and year 5 of the MAP.3 core study on the same Lunar or Hologic scanner.
The George Washington University, Washington D.C.
Suburban Hospital Cancer Program, Bethesda
Hutzel Women's Health Specialists, Detroit
Univ. of Wisconsin Center for Women's Health and, Madison
University of Oklahoma, Oklahoma City
Los Angeles Biomedical Research Institute, Torrance
Maine Center for Cancer Medicine and Blood Disorders, Scarborough
Massachusetts General Hospital, Boston
Dana-Farber Cancer Institute, Boston
University of Medicine and Dentistry of New Jersey, Newark
The Memorial Hospital of Rhode Island, Pawtucket
Fletcher Allen Health Care, Burlington
Fred Hutchinson Cancer Research Center, Seattle
BCCA - Cancer Centre for the Southern Interior, Kelowna
BCCA - Vancouver Cancer Centre, Vancouver
Northeast Cancer Center Health Sciences, Greater Sudbury
London Regional Cancer Program, London
Univ. Health Network-Princess Margaret Hospital, Toronto
Lead Sponsor
NCIC Clinical Trials Group
NETWORK