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The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate IV | Experimental | Participants will receive ibandronate 3 mg IV once every 3 months |
|
| Ibandronate Oral | Experimental | Participants will receive ibandronate 150 milligrams (mg) tablet once monthly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants | 12 months | |
| Percentage of participants with GI events based on severity | Up to 10 months |
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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 |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36116 | United States | |||
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| Percentage of participants who experienced a change in frequency and number of GI events | Up to 10 months |
| Lake Havasu City |
| Arizona |
| 86403 |
| United States |
| Paradise Valley | Arizona | 85253 | United States |
| Pine Bluff | Arkansas | 71603 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92108 | United States |
| Santa Monica | California | 90404 | United States |
| Tacoma | California | 98405 | United States |
| Vista | California | 92083 | United States |
| Beverly Hills | Florida | 34464 | United States |
| Fort Myers | Florida | 33901 | United States |
| Gainesville | Florida | 32605 | United States |
| Miami | Florida | 33186 | United States |
| Ocala | Florida | 34471 | United States |
| Palm Harbor | Florida | 34684 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Augusta | Georgia | 30904 | United States |
| Coeur d'Alene | Idaho | 83814 | United States |
| Champaign | Illinois | 61820 | United States |
| Evansville | Indiana | 47714 | United States |
| Natchitoches | Louisiana | 71457 | United States |
| South Portland | Maine | 04106 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Detroit | Michigan | 48236 | United States |
| Chaska | Minnesota | 55318 | United States |
| Kansas City | Missouri | 64114 | United States |
| St Louis | Missouri | 63033 | United States |
| Billings | Montana | 59101 | United States |
| Broken Bow | Nebraska | 68822 | United States |
| Scottsbluff | Nebraska | 69361 | United States |
| Las Vegas | Nevada | 89104 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| New York | New York | 10003 | United States |
| West Haverstraw | New York | 10993 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Durham | North Carolina | 27704 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Bismarck | North Dakota | 58501 | United States |
| Fargo | North Dakota | 58104 | United States |
| Canfield | Ohio | 44406 | United States |
| Columbus | Ohio | 43213 | United States |
| Mayfield | Ohio | 44143 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Loris | South Carolina | 29569 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Sioux Falls | South Dakota | 57105 | United States |
| Watertown | South Dakota | 57201 | United States |
| Bristol | Tennessee | 37620 | United States |
| Dallas | Texas | 75231 | United States |
| Denton | Texas | 76210 | United States |
| San Antonio | Texas | 78229 | United States |
| San Antonio | Texas | 78238 | United States |
| Seguin | Texas | 78155 | United States |
| Temple | Texas | 76508 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23294 | United States |
| Richmond | Virginia | 23298 | United States |
| Madison | Wisconsin | 53792 | 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 |
|---|---|
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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