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

NCT00688246 | Completed DMC

• 4 other identifiers: MAP3BCAN-NCIC-MAP3BPFIZER-NCIC-MAP3BCDR0000586285
• Study Type: observational
• Target: 238
• Locations: 2 countries
• Sites: 18

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.

Conditions

Breast Cancer; Osteoporosis

Keywords

osteoporosis; breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

biologic sample preservation procedure OTHER

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 PROCEDURE

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.

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible women consenting to be randomized to the core MAP.3 trial will be approached for participation in this companion study. They must have an acceptable quality BMD scan by DEXA taken within 12 months prior to randomization to MAP.3. A BMD T-score \> -2.0 SD (i.e. 2.0 standard deviations below the average peak BMD of a young adult woman) has been established as the study population cut-off because postmenopausal women who have BMD T-scores as low as or lower than - 2.0 SD are currently recommended to consider pharmacological therapies for their bones

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (18)

Los Angeles Biomedical Research Institute

Torrance, California, 90502, United States

Location

The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Maine Center for Cancer Medicine and Blood Disorders

Scarborough, Maine, 04074-9308, United States

Location

Suburban Hospital Cancer Program

Bethesda, Maryland, 20817, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hutzel Women's Health Specialists

Detroit, Michigan, 48201, United States

Location

University of Medicine and Dentistry of New Jersey

Newark, New Jersey, 07107, United States

Location

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

The Memorial Hospital of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Univ. of Wisconsin Center for Women's Health and

Madison, Wisconsin, 53715, United States

Location

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Northeast Cancer Center Health Sciences

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Breast Neoplasms; Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Paul E. Goss, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2008
• First Posted: June 2, 2008
• Study Start: July 10, 2008
• Primary Completion: October 31, 2011
• Study Completion: January 10, 2013
• Last Updated: August 4, 2023

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); CA (5)