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

Completed

• Conditions: Breast Cancer; Osteoporosis

• Registration Number: NCT00688246
• Lead Sponsor: NCIC Clinical Trials Group

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-02
• Study Start: 2008-07-10
• Primary Completion: 2011-10-31
• Study Completion: 2013-01-10
• Status Verified: 2020-03
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3	5 years
Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3	5 years
Development of osteoporosis either by sustaining a fragility fracture or by having a BMD T-score at or lower than - 2.5 SD at the spine (L1-L4) or total hip	2 years
Number of clinical skeletal fractures by radiology report	2 years

Trial Locations

Locations (18)

Los Angeles Biomedical Research Institute; 🇺🇸 Torrance, California, United States

The George Washington University; 🇺🇸 Washington, District of Columbia, United States

Maine Center for Cancer Medicine and Blood Disorders; 🇺🇸 Scarborough, Maine, United States

Suburban Hospital Cancer Program; 🇺🇸 Bethesda, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Hutzel Women's Health Specialists; 🇺🇸 Detroit, Michigan, United States

University of Medicine and Dentistry of New Jersey; 🇺🇸 Newark, New Jersey, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

The Memorial Hospital of Rhode Island; 🇺🇸 Pawtucket, Rhode Island, United States

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