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 has been completed.
Sponsor:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00688246
First received: May 30, 2008
Last updated: January 10, 2013
Last verified: July 2012
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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 |
Other: biologic sample preservation procedure Procedure: dual x-ray absorptometry |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Bone Density
Breast Cancer
Cancer
Fractures
Minerals
Osteoporosis
X-Rays
Drug Information available for:
Exemestane
U.S. FDA Resources
Further study details as provided by NCIC Clinical Trials Group:
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 [ Time Frame: 2 years ] [ 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 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3 [ Time Frame: 5 years ] [ 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of clinical skeletal fractures by radiology report [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Serum
| Enrollment: | 238 |
| Study Start Date: | January 2008 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: 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.
Procedure: 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.
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: | Yes |
| 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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688246
Locations
| United States, California | |
| Los Angeles Biomedical Research Institute | |
| Torrance, California, United States, 90502 | |
| United States, District of Columbia | |
| The George Washington University | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Maine | |
| Maine Center for Cancer Medicine and Blood Disorders | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Maryland | |
| Suburban Hospital Cancer Program | |
| Bethesda, Maryland, United States, 20817 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Hutzel Women's Health Specialists | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| University of Medicine and Dentistry of New Jersey | |
| Newark, New Jersey, United States, 07107 | |
| United States, Oklahoma | |
| University of Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Rhode Island | |
| The Memorial Hospital of Rhode Island | |
| Pawtucket, Rhode Island, United States, 02860 | |
| United States, Vermont | |
| Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05401 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| United States, Wisconsin | |
| Univ. of Wisconsin Center for Women's Health and | |
| Madison, Wisconsin, United States, 53715 | |
| Canada, British Columbia | |
| BCCA - Cancer Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| BCCA - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Ontario | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Northeast Cancer Center Health Sciences | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Univ. Health Network-Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
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
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00688246 History of Changes |
| Other Study ID Numbers: | MAP3B, CAN-NCIC-MAP3B, PFIZER-NCIC-MAP3B, CDR0000586285 |
| Study First Received: | May 30, 2008 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Canada: Health Canada United States: Food and Drug Administration |
Keywords provided by NCIC Clinical Trials Group:
|
osteoporosis breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Osteoporosis Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Bone Diseases, Metabolic Bone Diseases |
Musculoskeletal Diseases Exemestane Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013