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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and the hip by DXA. Each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy procedure will be repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alendronate 3 to < 5 years | Alendronate (any combination of 10 mg daily or 70 mg once weekly) 3- 5 years. | ||
| Risedronate 3 to < 5 Years | Risedronate (any combination of 5 mg daily or 35 mg once weekly) 3-5 years. | ||
| Alendronate ≥ 5 Years | Alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than or equal to 5 years. | ||
| Risedronate ≥ 5 Years | Risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than or equal to 5 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Compare iliac crest bone histomorphometry and bone quality changes after 5 years of more of alendronate or risedronate therapy with 3 years of therapy in PMO women | one year |
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Inclusion Criteria:
Exclusion Criteria:
Uncontrolled hyperthyroidism. Previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin.
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Outpatients from bone research centers who have taken alendronate or risedronate for 3 to 5 or more years
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| Name | Affiliation | Role |
|---|---|---|
| Stephen R Marcello, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Research Facility | Palm Desert | California | 92269 | United States | ||
| Warner Chilcott Research Facility |
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bone biopsies
| Lakewood |
| Colorado |
| 80227 |
| United States |
| Warner Chilcott Research Facility | Decatur | Georgia | 30033 | United States |
| Warner Chilcott Research Facility | Gainesville | Georgia | 30501 | United States |
| Warner Chilcott Research Facility | Omaha | Nebraska | 68131 | United States |
| Warner Chilcott Research Facility | Cincinnati | Ohio | 45219 | United States |
| Warner Chilcott Research Facility | Wyomissing | Pennsylvania | 19610 | United States |
| Warner Chilcott Research Facility | Montreal | Quebec | H2X 1P1 | Canada |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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