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This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Ibandronate Then Alendronate | Experimental | Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks. |
|
| Group B: Alendronate Then Ibandronate | Experimental | Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate | Drug | Participants wil receive once-weekly oral alendronate (70 mg tablet) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. | Up to 6 months | |
| Incidence of adverse events | Up to approximately 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
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| Ibandronate | Drug | Participants wil receive once-monthly oral ibandronate (150 mg tablet) |
|
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Tempe | Arizona | 85282 | United States |
| Laguna Woods | California | 92653 | United States |
| Mission Viejo | California | 92691 | United States |
| Oceanside | California | 92056 | United States |
| San Diego | California | 92103-6204 | United States |
| San Diego | California | 92108 | United States |
| Santa Clarita | California | 91321 | United States |
| Upland | California | 91786 | United States |
| Vista | California | 92084 | United States |
| Denver | Colorado | 80202 | United States |
| Cromwell | Connecticut | 06416 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Newark | Delaware | 19713 | United States |
| Aventura | Florida | 33180 | United States |
| Miami | Florida | 33176 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Tampa | Florida | 33614 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Augusta | Georgia | 30904 | United States |
| Decatur | Georgia | 30033 | United States |
| Chicago | Illinois | 60612 | United States |
| Indianapolis | Indiana | 46202 | United States |
| South Bend | Indiana | 46601 | United States |
| Des Moines | Iowa | 50314 | United States |
| Wichita | Kansas | 67207 | United States |
| Bangor | Maine | 04401 | United States |
| Baltimore | Maryland | 21209 | United States |
| Worcester | Massachusetts | 01610 | United States |
| Florissant | Missouri | 63031 | United States |
| St Louis | Missouri | 63128 | United States |
| Reno | Nevada | 89502 | United States |
| Princeton | New Jersey | 08540 | United States |
| Toms River | New Jersey | 08753 | United States |
| Orchard Park | New York | 14127 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Eugene | Oregon | 97401 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Erie | Pennsylvania | 16502 | United States |
| Erie | Pennsylvania | 16506 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Philadelphia | Pennsylvania | 19148 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Warwick | Rhode Island | 02886 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Nashville | Tennessee | 37203 | United States |
| Dallas | Texas | 75234 | United States |
| Houston | Texas | 77024 | United States |
| Newport News | Virginia | 23602 | United States |
| Richmond | Virginia | 23235 | United States |
| Seattle | Washington | 98105 | United States |
| Seattle | Washington | 98144 | United States |
| Madison | Wisconsin | 53705 | United States |
| 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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| ID | Term |
|---|---|
| D019386 | Alendronate |
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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