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The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: | 70 women with hormone-dependent or hormone-independent early breast cancer that have completed their chemo- and/or radiotherapy just recently (up to 6 months after completion of therapy) | ||
| B | 70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy | ||
| C | 70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy | ||
| D | 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy | ||
| E | 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy | ||
| F | 70 women with hormone-dependent early breast cancer, 54-66 months after initiation of tamoxifen therapy | ||
| G |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of aromatase inhibitors therapy on bone mineral density as measured by DEXA scan and compare it to the effects of tamoxifen and no hormonal therapy. | once |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the bone fracture rate in women on aromatase inhibitors therapy and compare it to fracture rates observed in the tamoxifen and the hormone-independent group. | once |
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Inclusion Criteria:
Exclusion Criteria:
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Institute of Oncology
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| Name | Affiliation | Role |
|---|---|---|
| Simona Borstnar, MD, PhD | Institute of Oncology Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ljubljana | Slovenia |
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70 women with hormone-dependent early breast cancer, 54-66 months after initiation of aromatase inhibitors therapy
| H | 70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy following 24-36 months of initial tamoxifen therapy |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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