Full Text View
Tabular View
No Study Results Posted
Related Studies
Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer And Who Are Receiving Exemestane on Clinical Trial CAN-NCIC-MAP3
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: May 30, 2008   Last Updated: June 3, 2009   History of Changes
Sponsor: NCIC Clinical Trials Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00688246
  Purpose

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.


Condition Intervention
Breast Cancer
Osteoporosis
Drug: exemestane
Other: biologic sample preservation procedure
Other: physiologic testing
Procedure: dual x-ray absorptometry

Study Type: Observational
Official Title: The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3 [ Designated as safety issue: No ]
  • Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Number of clinical skeletal fractures by radiology report [ Designated as safety issue: No ]

Estimated Enrollment: 480
Study Start Date: January 2008
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • Blood samples for baseline bone biomarkers collected within 8 weeks prior to randomization to CAN-NCIC-MAP3
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688246

Locations
United States, California
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
Contact: Rowan Chlebowski     310-222-2217        
United States, District of Columbia
George Washington University Medical Center Recruiting
Washington, District of Columbia, United States, 20037
Contact: Clinical Trials Office - George Washington University Medical     202-741-2981        
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough Recruiting
Scarborough, Maine, United States, 04074-9308
Contact: Tracey F. Weisberg     207-885-7600        
United States, Maryland
Suburban Hospital Cancer Program Recruiting
Bethesda, Maryland, United States, 20817
Contact: Carolyn Hendricks     301-897-1503        
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Judy E. Garber     617-632-3800        
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital     877-726-5130        
United States, Michigan
Hutzel Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Susan Hendrix     313-745-0499        
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
United States, Oklahoma
Oklahoma University Cancer Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: William C. Dooley     405-271-7867        
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Michele Cyr     401-444-8537        
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Health Care     802-656-8990        
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Anne McTiernan     206-667-6196        
United States, Wisconsin
University of Wisconsin Center for Women's Health Research Recruiting
Madison, Wisconsin, United States, 53715
Contact: Gloria E. Sarto     608-267-5572        
Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Susan Ellard     250-712-3922        
British Columbia Cancer Agency - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Karen Gelmon     604-877-6000        
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Eric W. Winquist     519-685-8640        
Northeastern Ontario Regional Cancer Centre Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Contact: Amanda Hey     705-522-6237        
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Angela M. Cheung     416-340-4301        
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
Study Chair: Paul E. Goss, MD, PhD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000586285, CAN-NCIC-MAP3B, PFIZER-NCIC-MAP3B
Study First Received: May 30, 2008
Last Updated: June 3, 2009
ClinicalTrials.gov Identifier: NCT00688246     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
osteoporosis
breast cancer

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Breast Neoplasms
Osteoporosis
Bone Diseases, Metabolic
Enzyme Inhibitors
Bone Diseases
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Therapeutic Uses
Osteoporosis, Postmenopausal
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010