Effects of Exemestane on Bone Strength

NCT01144468 | Completed Results

• 1 other identifier: 07-0168
• Study Type: observational
• Target: 351
• Locations: 2 countries
• Sites: 4

Brief Summary

The NCIC CTG was conducting an international breast cancer prevention trial (MAP.3) examining the effects of a new therapy (exemestane) for breast cancer prevention in postmenopausal women at increased risk of developing this disease. Results showed that after a median follow up of 35 months, exemestane was superior to placebo in breast cancer prevention. Exemestane blocks estrogen production, which may be beneficial for preventing breast cancer, but may have negative effects on bone. As postmenopausal women are at risk for developing osteoporosis, determining whether exemestane causes bones to weaken is crucial for women considering it for long-term use. Dr. Cheung's team followed the bone health of 354 women in MAP.3 in detail over 2 years and found that volumetric bone mineral density (by high resolution peripheral quantitative computer tomography (HR-pQCT) at the radius and tibia as well as areal bone mineral density by dual energy x-ray absorptiometry (DXA) at the hip and spine decreased significantly with the use of exemestane. The long term effects of exemestane on bone will be examined up to 5 years of therapy and then 2 years post therapy to delineate the effects of exemestane on bone strength. This research will inform us on the safety of exemestane for breast cancer prevention.

Conditions

Osteoporosis; Breast Cancer

Keywords

breast cancer prevention; osteoporosis

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in Total Volumetric Bone Mineral Density (BMD) Measured by High Resolution Peripheral Quantitative Computer Tomography (HR-PQCT) From Baseline to 24 Months

  Mean percent change in total volumetric bone mineral density (BMD) measured by high resolution peripheral quantitative computer tomography )HR-pQCT from baseline to 24 months

  24 months

Study Arms (1)

MAP3 Participants

study participants in the MAP.3 study are randomly assigned to either placebo or 25 mg exemestane daily for 5 years. Allocation is blinded. We are following 354 of these study participants and are blinded to treatment allocation.

Eligibility Criteria

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

Study Population

Women randomized to the MAP.3 study from 5 participating locations were consecutively approached for participation in this companion study.

You may qualify if:

• Women participating in the MAP.3 clinical trial at centres with access to HR-pQCT

You may not qualify if:

• Women with osteoporosis;
• Women with T-score of -2.0 or below at the lumbar spine (L1-L4), total hip or femoral neck;
• Women with a fragility fracture after age 40;
• Women who have been on any bone drug, such as hormone replacement therapy, selective estrogen receptor modulators, bisphosphonates, teriparatide, parathyroid hormone, sodium fluoride, strontium, calcitonin and high dose vitamin D (more than 2000iu of vitamin D3 daily),in the past 3 months;
• Women who have ever been on a bisphosphonate for more than 6 months;
• Women who have ever been on strontium for more than 1 month;
• Women who are on chronic oral steroids (the equivalent of 5mg of prednisone a day or higher for more than 2 weeks within the past 6 months and will likely require ongoing therapy);
• Women with Paget's disease, Cushing's disease, hyperparathyroidism, uncontrolled hyperthyroidism or other metabolic bone diseases;
• Women with decompensated diseases of the liver, bowel, kidney, pancreas, lung, or heart.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Breast Cancer Research Alliance: collaborator

Study Sites (4)

University of California Davis

Sacramento, California, 95817, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University Health Network, TGH

Toronto, Ontario, M5G 2C4, Canada

Location

Women's College Hospital

Toronto, Ontario, M5S 1B6, Canada

Location

Related Publications (2)

• Goss PE, Ingle JN, Ales-Martinez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson KC, Martin LW, Winquist E, Sarto GE, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H; NCIC CTG MAP.3 Study Investigators. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4.

  PMID: 21639806 BACKGROUND

• Cheung AM, Tile L, Cardew S, Pruthi S, Robbins J, Tomlinson G, Kapral MK, Khosla S, Majumdar S, Erlandson M, Scher J, Hu H, Demaras A, Lickley L, Bordeleau L, Elser C, Ingle J, Richardson H, Goss PE. Bone density and structure in healthy postmenopausal women treated with exemestane for the primary prevention of breast cancer: a nested substudy of the MAP.3 randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):275-84. doi: 10.1016/S1470-2045(11)70389-8. Epub 2012 Feb 7.

  PMID: 22318095 RESULT

MeSH Terms

Conditions

Osteoporosis; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Angela Cheung
• Organization: University Health Network

jscher@uhnresearch.ca

416-340-4841

Study Officials

• Angela MW Cheung, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: June 11, 2010
• First Posted: June 15, 2010
• Study Start: April 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: January 1, 2022
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2022-11

Locations

US (2); CA (2)