Status:
COMPLETED
Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Breast Cancer
Osteoporosis
Eligibility:
FEMALE
35+ years
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 he...
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 randomizatio...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 10 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2013
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00688246
Start Date
July 10 2008
End Date
January 10 2013
Last Update
August 4 2023
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
2
The George Washington University
Washington D.C., District of Columbia, United States, 20037
3
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074-9308
4
Suburban Hospital Cancer Program
Bethesda, Maryland, United States, 20817