Clinical trial · Observational
Bone Mineral Density in Postmenopausal Women at Increased Risk of Breast Cancer And Who Are Receiving Exemestane on MAP3
The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biologic sample preservation procedure | Other | — | UNRESOLVED |
| dual x-ray absorptometry | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- 2 years
Secondary outcomes (4)
- measure
- Change in BMD as measured by DEXA scans of the spine (L1-L4) and total hip 5 years after randomization on CAN-NCIC-MAP3
- timeFrame
- 5 years
- measure
- Changes in markers of bone formation and resorption 1 and 5 years after randomization on CAN-NCIC-MAP3
- timeFrame
- 5 years
- measure
- 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
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
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
References
Publications (0)
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