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

NCT00688246 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 238

Last updated 2023-08-04

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • NCIC Clinical Trials Group

    lead NETWORK

Principal Investigators

  • Paul E. Goss, MD, PhD · Massachusetts General Hospital

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-10
Primary Completion
2011-10-31
Completion
2013-01-10

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00688246 on ClinicalTrials.gov