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| ID | Type | Description | Link |
|---|---|---|---|
| SABRE |
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The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum |
|
| 2 | Experimental | Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum |
|
| 3 | Experimental | Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole | Drug | 1mg/Day Oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) | Assessed at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total hip BMD | Assessed at 12 and 24 months | |
| Change from baseline in lumbar spine (L1-L4) BMD | Assessed at 24 months | |
| Change from baseline in bone formation markers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Arimidex Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Palm Springs | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38979716 | Derived | Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2. |
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| Risedronate Sodium | Drug | 35mg/week, oral |
|
|
| Assessed at 6 and12 months |
| Change from baseline in bone resorption and formation markers | Assessed at 6 and 12 months |
| Change from baseline in LDL-cholesterol | Assessed at 12 months |
| Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides | Assessed at 3, 6 and 12 months |
| Jacksonville |
| Florida |
| United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | New York | New York | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Pittsburgh | Pennsylvania | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Burnaby | Canada |
| Research Site | Edmonton | Canada |
| Research Site | Montreal | Canada |
| Research Site | Québec | Canada |
| Research Site | Vancouver | Canada |
| Research Site | Bordeaux | France |
| Research Site | Caen | France |
| Research Site | Lyon | France |
| Research Site | Saint-Cloud | France |
| Research Site | Saint-Herblain | France |
| Research Site | Athens | Greece |
| Research Site | Irakleio | Greece |
| Research Site | Goes | Netherlands |
| Research Site | Ijssel | Netherlands |
| Research Site | Nijmegen | Netherlands |
| Research Site | The Hague | Netherlands |
| Research Site | Bloemfontain | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Tygerberg | South Africa |
| Research Site | Pamplona | Spain |
| Research Site | Pontevedra | Spain |
| Research Site | Seville | Spain |
| Research Site | Valencia | Spain |
| Research Site | Belfast | United Kingdom |
| Research Site | Bolton | United Kingdom |
| Research Site | Dundee | United Kingdom |
| Research Site | Luton | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001851 | Bone Diseases, Metabolic |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D011725 | Pyridines |
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