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This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibandronate | Experimental | Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibandronate | Drug | Film-coated oral ibandronate tablet (150 mg) once-monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ) | Up to 30 days prior to baseline visit | |
| Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate | 6 months | |
| Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B | Screening visit | |
| Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate |
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Inclusion Criteria:
- Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (>=) 3 months
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35235 | United States | |||
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| 6 months |
| Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate | 6 months |
| Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance | 6 months |
| Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms | 6 months |
| Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) | 6 months |
| Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) | Baseline and 6 months |
| Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B | Screening Visit |
| Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate | 6 months |
| Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate | 6 months |
| Part B: Number of participants who have >= 80% compliance | 6 months |
| Part B: Number of participants who report an improvement in the GI symptoms | 6 months |
| Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) | 6 months |
| Columbiana |
| Alabama |
| 35051 |
| United States |
| Huntsville | Alabama | 35801 | United States |
| Mobile | Alabama | 36608 | United States |
| Montgomery | Alabama | 36111 | United States |
| Chandler | Arizona | 85225 | United States |
| Gilbert | Arizona | 85295 | United States |
| Paradise Valley | Arizona | 85253 | United States |
| Phoenix | Arizona | 85006 | United States |
| Phoenix | Arizona | 85014 | United States |
| Tempe | Arizona | 85282 | United States |
| Tucson | Arizona | 85712 | United States |
| Carlisle | Arkansas | 72024 | United States |
| Jonesboro | Arkansas | 72401 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Pine Bluff | Arkansas | 71603 | United States |
| Rogers | Arkansas | 72756 | United States |
| Searcy | Arkansas | 72143 | United States |
| Sherwood | Arkansas | 72120 | United States |
| Anaheim | California | 92801 | United States |
| Beverly Hills | California | 90211 | United States |
| Laguna Hills | California | 92653 | United States |
| Mission Viejo | California | 92691 | United States |
| Palm Desert | California | 92260 | United States |
| Palo Alto | California | 94304 | United States |
| Sacramento | California | 95825 | United States |
| San Diego | California | 92128 | United States |
| Tacoma | California | 98405 | United States |
| Vista | California | 92083 | United States |
| Westlake Village | California | 91361 | United States |
| Colorado Springs | Colorado | 80909 | United States |
| Lakewood | Colorado | 80260 | United States |
| Avon | Connecticut | 06001 | United States |
| Cromwell | Connecticut | 06416 | United States |
| Hamden | Connecticut | 06518 | United States |
| New London | Connecticut | 06320 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Wilmington | Delaware | 19805 | United States |
| Aventura | Florida | 33180 | United States |
| Clearwater | Florida | 33761 | United States |
| DeLand | Florida | 32720 | United States |
| Fort Myers | Florida | 33916 | United States |
| Gainesville | Florida | 32605 | United States |
| Gainesville | Florida | 32607 | United States |
| Longwood | Florida | 32779 | United States |
| Melbourne | Florida | 32901 | United States |
| Miami | Florida | 33186 | United States |
| Ocala | Florida | 34471 | United States |
| Palm Bay | Florida | 32905 | United States |
| Palm Harbor | Florida | 34684 | United States |
| Port Orange | Florida | 32127 | United States |
| Sarasota | Florida | 34239 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Atlanta | Georgia | 30309 | United States |
| Augusta | Georgia | 30904 | United States |
| Decatur | Georgia | 30033 | United States |
| Rome | Georgia | 30165 | United States |
| Boise | Idaho | 83712 | United States |
| Coeur d'Alene | Idaho | 83814 | United States |
| Champaign | Illinois | 61820 | United States |
| Creve Coeur | Illinois | 61610 | United States |
| Peoria | Illinois | 61615 | United States |
| Evansville | Indiana | 47714 | United States |
| Arkansas City | Kansas | 67005 | United States |
| Newton | Kansas | 67114 | United States |
| Wichita | Kansas | 67207 | United States |
| Natchitoches | Louisiana | 71457 | United States |
| New Orleans | Louisiana | 70119 | United States |
| Baltimore | Maryland | 21204 | United States |
| Bethesda | Maryland | 20817 | United States |
| Chelsea | Michigan | 48118 | United States |
| Detroit | Michigan | 48202 | United States |
| Saint Joseph | Michigan | 49085 | United States |
| Chaska | Minnesota | 55318 | United States |
| Jefferson City | Missouri | 65109 | United States |
| Kansas City | Missouri | 64108 | United States |
| Kansas City | Missouri | 64114 | United States |
| St Louis | Missouri | 63110 | United States |
| St Louis | Missouri | 63117 | United States |
| St Louis | Missouri | 63128 | United States |
| St Louis | Missouri | 63141 | United States |
| Billings | Montana | 59101 | United States |
| Omaha | Nebraska | 68131 | United States |
| Clifton | New Jersey | 07012 | United States |
| Middletown | New Jersey | 07748 | United States |
| New Brunswick | New Jersey | 08901 | United States |
| Princeton | New Jersey | 08540 | United States |
| Brooklyn | New York | 11201 | United States |
| East Syracuse | New York | 13057 | United States |
| New York | New York | 10011 | United States |
| Olean | New York | 14760 | United States |
| Rochester | New York | 14609 | United States |
| Stony Brook | New York | 11794-8161 | United States |
| Durham | North Carolina | 27704 | United States |
| Durham | North Carolina | 27705 | United States |
| Fayetteville | North Carolina | 28304 | United States |
| Morehead City | North Carolina | 28557 | United States |
| Morganton | North Carolina | 28655 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Fargo | North Dakota | 58103 | United States |
| Grand Forks | North Dakota | 58201 | United States |
| Beachwood | Ohio | 44122 | United States |
| Canfield | Ohio | 44406 | United States |
| Cincinnati | Ohio | 45246 | United States |
| Columbus | Ohio | 43213 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Medford | Oregon | 97504 | United States |
| Portland | Oregon | 97210 | United States |
| Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Langhorne | Pennsylvania | 19047 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Philadelphia | Pennsylvania | 19131 | United States |
| Wyomissing | Pennsylvania | 19610 | United States |
| Charleston | South Carolina | 29425 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Spartanburg | South Carolina | 29307 | United States |
| Bristol | Tennessee | 37620 | United States |
| Memphis | Tennessee | 38103 | United States |
| Murfreesboro | Tennessee | 37130 | United States |
| Nashville | Tennessee | 37203 | United States |
| Sevierville | Tennessee | 37862 | United States |
| Carrollton | Texas | 75010 | United States |
| Corpus Christi | Texas | 78414 | United States |
| Dallas | Texas | 75231 | United States |
| Denton | Texas | 76210 | United States |
| San Antonio | Texas | 78229 | United States |
| Wichita Falls | Texas | 76309 | United States |
| Norfolk | Virginia | 23502 | United States |
| Norfolk | Virginia | 23507-1912 | United States |
| Richmond | Virginia | 23226 | United States |
| Richmond | Virginia | 23294 | United States |
| Renton | Washington | 98055 | United States |
| Seattle | Washington | 98105 | United States |
| Seattle | Washington | 98144 | United States |
| Spokane | Washington | 99207 | United States |
| Tacoma | Washington | 98405 | United States |
| Madison | Wisconsin | 53705 | United States |
| Milwaukee | Wisconsin | 53209 | 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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