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Aromatase inhibitor therapy is in France the adjuvant reference treatment for postmenopausal women with early-stage breast cancer. This treatment induces bone loss and a higher risk of fractures.
This study aimed to document the effect of bisphosphonate therapy in preventing bone loss and osteoporotic fractures in postmenopausal women with aromatase inhibitor treatment for breast cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Placebo Comparator | Patients receive placebo 35 mg once a week plus a calcium and vitamin D supplementation. Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment |
|
| 1 | Active Comparator | Patients receive risedronate 35 mg once a week plus a calcium and vitamin D supplementation. Measure of bone density, bone markers, clinical examination and questionnaire regarding fractures will be assessed at 12 and 24 months of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate | Drug | 35mg oral risedronate once per week for 24 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the lumbar spine Bone Mineral Density after one year of treatment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of femoral BMD after one year of treatment | 1 year | |
| Evolution of lumbar spine and femoral BMD after two years of treatment | 2 years | |
| Evolution of bone resorption and formation markers |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aurélie Fontana, M.D | Hôpital Edouard Herriot | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rhumatology et de Pathologie Osseuse, Hôpital Edouard Herriot | Lyon | 69437 | France |
| 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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| 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 |
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| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Placebo 35 mg once a week for 24 months |
|
| 2 years |
| Proportion of fractures after two years of treatment | 2 years |
| Evolution of estradiol levels | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |