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Bone Mineral Density (BMD) as measured by X-ray shows the amount of calcium in the bone. Low BMD may reflect osteoporosis, a condition where there is an increased risk of fracture. Women who have gone through menopause have a higher risk of getting osteoporosis because they lose calcium from their bones much faster than younger women. Women with breast cancer may have an additional risk for getting osteoporosis because of the effects of their treatment with chemotherapy. The purpose of this study is to see what levels of BMD post-menopausal women with breast cancer have, and to see if the level of BMD changes during a women's treatment after her surgery. This trial studies changes in BMD and markers of bone activity in women receiving treatment for early stage breast cancer.
Breast cancer patients may be at increased risk for osteoporosis secondary to cancer treatment. The hypothesis of this study is that adjuvant chemotherapy increases the risk of osteoporosis in postmenopausal women. The objective of this pilot study is to describe the effects of chemotherapy on bone mineral density and serum markers of bone metabolism.
There is limited data on the change in bone mineral density due to chemotherapy in postmenopausal women. This prospective study will gather data on the effects of systemic breast cancer therapy on bone mineral density in postmenopausal women receiving adjuvant care for early stage (0, I, II or III) breast cancer. Postmenopausal women are the focus of this study because: (1) they are the largest subgroup of women with breast cancer (2) they are expected to have a rate of BMD loss unless disturbed by disease or medications, unlike the pre and perimenopausal women whose BMD is dramatically affected by changes in hormonal status (3) this group of patients is at greatest risk for acute osteoporotic fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bone Mineral Density |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Mineral Density | Other | Clinic visits twice during the first 2 years of the study with medical care directed by your treating doctor.BMD is measured by an X-ray test. The most common type of BMD testing is by energy x-ray absorptiometry (DEXA). Usually BMD is measured every other year, but to closely monitor women on this study, the BMD will be evaluated more often. The BMD will be measured 3 times (baseline, 12 months and 24 months) on this study. Study blood work is obtained three times (baseline, 6 months, and 12 months). Blood (about 3 teaspoons). |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the rate of change in bone mineral density in postmenopausal women undergoing adjuvant chemotherapy with dose dense doxorubicin, cyclophosphamide and paclitaxel (AC-T or A-T-C) for early stage breast cancer. | conclusion of study |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the rate of change in markers of bone metabolism in postmenopausal women undergoing adjuvant chemotherapy with doxorubicin, cyclophosphamide and paclitaxel (AC-T or A-T-C) for early stage breast cancer. | conclusion of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriella Dandrea, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan-Kettering Cancer Center |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015519 | Bone Density |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Commack |
| New York |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |