Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3

CompletedOBSERVATIONAL
Enrollment

238

Participants

Timeline

Start Date

July 10, 2008

Primary Completion Date

October 31, 2011

Study Completion Date

January 10, 2013

Conditions
Breast CancerOsteoporosis
Interventions
OTHER

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.

PROCEDURE

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.

Trial Locations (18)

20037

The George Washington University, Washington D.C.

20817

Suburban Hospital Cancer Program, Bethesda

48201

Hutzel Women's Health Specialists, Detroit

53715

Univ. of Wisconsin Center for Women's Health and, Madison

73104

University of Oklahoma, Oklahoma City

90502

Los Angeles Biomedical Research Institute, Torrance

04074-9308

Maine Center for Cancer Medicine and Blood Disorders, Scarborough

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber Cancer Institute, Boston

07107

University of Medicine and Dentistry of New Jersey, Newark

02860

The Memorial Hospital of Rhode Island, Pawtucket

05401

Fletcher Allen Health Care, Burlington

98109-1024

Fred Hutchinson Cancer Research Center, Seattle

V1Y 5L3

BCCA - Cancer Centre for the Southern Interior, Kelowna

V5Z 4E6

BCCA - Vancouver Cancer Centre, Vancouver

P3E 5J1

Northeast Cancer Center Health Sciences, Greater Sudbury

N6A 4L6

London Regional Cancer Program, London

M5G 2M9

Univ. Health Network-Princess Margaret Hospital, Toronto

Sponsors
All Listed Sponsors
lead

NCIC Clinical Trials Group

NETWORK