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

NCT ID: NCT00688246

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 238 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-10
• Study Completion Date: 2013-01-10

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.

Conditions

Breast Cancer; Osteoporosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• At increased risk of developing breast cancer and enrolled on clinical trial CAN-NCIC-MAP3
• Bone mineral density (BMD) (as measured by dual x-ray absorptometry [DEXA] scans within 12 months prior to randomization to the core protocol [MAP.3]) T score > -2.0 standard deviation (i.e., 2.0 standard deviations below the average peak BMD of a young adult woman) of spine (L1-L4) and total hip
• Serum for bone biomarkers (i.e., serum N-telopeptide and serum amino-terminal procollagen 1 extension peptide) must have been obtained within 8 weeks prior to registration to the study

PATIENT CHARACTERISTICS:

• Postmenopausal, defined as one of the following:

• Over 50 years of age with no spontaneous menses for at least 12 months before study entry
• 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry AND with follicle-stimulating hormone level within postmenopausal range
• Underwent prior bilateral oophorectomy
• Available for collection of serum samples and BMD (DEXA) scans at the protocol defined times (i.e., have BMD scans at years 2 and 5 at the same site)
• No history of fragility fractures (i.e., a broken bone that occurs with a fall from a standing height or lesser amount of trauma)
• No malabsorption syndrome (e.g., untreated celiac disease, clinically relevant vitamin D deficiency, or active hyper- or hypoparathyroidism)
• No Paget disease or other metabolic bone diseases (e.g., osteomalacia or osteogenesis imperfecta)
• No Cushing disease or other pituitary diseases
• No inflammatory disease(s) (e.g., inflammatory bowel disease, rheumatoid arthritis, lupus, psoriasic arthritis, ankylosing spondylitis, or autoimmune hepatitis)

PRIOR CONCURRENT THERAPY:

• More than 3 months since prior bone drugs, such as bisphosphonates, teriparatide (parathyroid hormone [PTH]), sodium fluoride, calcitonin (Miacalcin®), strontium, or high-dose vitamin D (i.e., vitamin D3 > 2,000 IU/day or calcitriol)
• No prior bisphosphonate therapy duration of more than 6 months total during lifetime
• No concurrent anabolic or chronic oral corticosteroids (the equivalent of 5 mg of prednisone a day or higher for more than 2 weeks within the past 6 months and will likely require ongoing therapy)
• Concurrent inhaled steroids allowed
• No concurrent medication that may have an effect on study endpoints for this study, including any of the following:

• Anticonvulsants
• Sodium fluoride at daily doses > 5 mg/day for a period exceeding 1 month
• Anabolic steroids
• Teriparatide (parathyroid hormone)
• Bisphosphonates, except for women who develop osteoporosis while on this study; these patients may be advised to start bone medication (i.e., strontium, calcitonin, or high-dose Vitamin D (i.e., Vitamin D3 > 2000 IU/day or calcitriol) at the discretion of their physician

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul E. Goss, MD, PhD

Role: STUDY_CHAIR

Massachusetts General Hospital

Locations

Los Angeles Biomedical Research Institute

Torrance, California, United States

The George Washington University

Washington D.C., 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

Fletcher Allen Health Care

Burlington, Vermont, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Univ. of Wisconsin Center for Women's Health and

Madison, Wisconsin, United States

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

CAN-NCIC-MAP3B

Identifier Type: REGISTRY

Identifier Source: secondary_id

PFIZER-NCIC-MAP3B

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000586285

Identifier Type: OTHER

Identifier Source: secondary_id

MAP3B

Identifier Type: -

Identifier Source: org_study_id