Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risedronate | Drug | 35mg po weekly for 12 weeks |
| |
| ibandronate [Bonviva/Boniva] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294-3708 | United States | |||
Not provided
Of the 488 patients who were screened, 356 patients were enrolled into the study at 44 centers in the USA and randomized to treatment with ibandronate and risedronate. One hundred eighty patients were randomized to Sequence A (Period 1 ibandronate, Period 2 risedronate), and 176 patients to Sequence B (Period 1 risedronate, Period 2 ibandronate).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A | Ibandronate followed by risedronate |
| FG001 | Sequence B | Risedronate followed by ibandronate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
150mg po monthly for 3 months |
|
| within 6 months |
| Intensity of Upper Gastrointestinal (GI) Symptoms | Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list. | within 3 months |
| Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) | During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made. | 3 months |
| Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) | During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made. | 3 months |
| Mesa |
| Arizona |
| 85213 |
| United States |
| Scottsdale | Arizona | 85251 | United States |
| Jonesboro | Arkansas | 72401 | United States |
| Anaheim | California | 92801 | United States |
| San Diego | California | 92108 | United States |
| Waterbury | Connecticut | 06708 | United States |
| Boynton Beach | Florida | 33437 | United States |
| Jupiter | Florida | 33458 | United States |
| Largo | Florida | 33777 | United States |
| Leesburg | Florida | 34748 | United States |
| Merritt Island | Florida | 32952 | United States |
| Ocala | Florida | 34471 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Spring Hill | Florida | 34667 | United States |
| St. Petersburg | Florida | 33606 | United States |
| Tampa | Florida | 33614 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Douglasville | Georgia | 30134 | United States |
| Gainesville | Georgia | 30501 | United States |
| Marietta | Georgia | 30060 | United States |
| Madisonville | Kentucky | 42431 | United States |
| Bethesda | Maryland | 20817 | United States |
| Missoula | Montana | 59801 | United States |
| Omaha | Nebraska | 68134 | United States |
| Morehead City | North Carolina | 28557 | United States |
| New Bern | North Carolina | 28562 | United States |
| Jamestown | North Dakota | 58401 | United States |
| Cincinnati | Ohio | 45224 | United States |
| Cincinnati | Ohio | 45236 | United States |
| Mogadore | Ohio | 44260 | United States |
| Tulsa | Oklahoma | 74104 | United States |
| Duncansville | Pennsylvania | 16635 | United States |
| Erie | Pennsylvania | 16506 | United States |
| Feasterville | Pennsylvania | 19053 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Anderson | South Carolina | 29621 | United States |
| Memphis | Tennessee | 38120 | United States |
| Selmer | Tennessee | 38375 | United States |
| Bedford | Texas | 76021 | United States |
| Bryan | Texas | 77802 | United States |
| Dallas | Texas | 75231 | United States |
| Houston | Texas | 77024 | United States |
| Houston | Texas | 77030 | United States |
| Temple | Texas | 76502 | United States |
| Richmond | Virginia | 23235 | United States |
| Richmond | Virginia | 23294 | United States |
| Seattle | Washington | 98105 | United States |
| Randomized |
|
| Did Not Receive Study Treatment |
|
| Received Treatment |
|
| Safety Analysis Set: Period 1 |
|
| Safety Analysis Set: Period 2 |
|
| Safety Analysis Set: Ibandronate |
|
| Safety Analysis Set: Risedronate |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sequence A | Ibandronate followed by risedronate |
| BG001 | Sequence B | Risedronate followed by ibandronate |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Preferred Ibandronate Monthly Dosing to Risedronate Weekly Dosing | Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. | Modified Intent to Treat (mITT), defined as the safety analysis set excluding those participants who did not express a preference for one treatment | Posted | Number | percentage of participants | at 6 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Found Once-monthly Ibandronate to be More Convenient Than Once-weekly Risedronate | Patients who had taken at least one dose of each study medication were asked to answer a Preference Questionnaire (answered by patients before any study procedures took place at the 6 month visit or at the early termination visit). The questionnaire included three questions on the preferred dosing schedule, and one question asking which schedule was more convenient. No assistance was allowed in completing the questionnaire. | mITT, defined as the safety analysis set excluding those participants who did not express a preference for one treatment | Posted | Number | percentage of participants | within 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensity of Upper Gastrointestinal (GI) Symptoms | Patients were given a diary in which to record their upper GI events during the first 12 weeks of treatment. The diary was to be completed weekly and the occurrence of symptoms and their intensity recorded using a pre-defined list. | Safety analysis set | Posted | Number | percentage of participants | within 3 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) | During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made. | Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported. | Posted | 3 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Median Change From Baseline in Bone Resorption and Bone Formation Markers, Serum C-telopeptide of α-chain of Type I Collagen (CTX) and Bone Specific Alkaline Phosphatase (BSAP) | During the conduct of this study, it came to the attention of the sponsor that mislabeling of blood samples for the analysis of the bone turnover markers, serum CTX and BSAP, had occurred at more than half of the 44 clinical trial sites. As a result of this mislabeling, the bone turnover marker samples could not be assigned correctly to the two time points at which they were collected (samples collected at baseline and those collected at the crossover visit which occurred after 3 months following the start of trial treatment). Thus, the results of bone turnover markers could not be reliably assessed. Therefore, summary tables showing the mean and median change from baseline for both serum CTX and BSAP for patients randomized to Sequence A (3 months of ibandronate followed by 12 weeks of risedronate) or Sequence B (12 weeks of risedronate followed by 3 months of ibandronate) are not presented, as a valid interpretation of the data cannot be made. | Mislabeling of blood samples for analysis of bone turnover markers resulted in inability to correctly assign samples to two time points at which they were collected (baseline and crossover visit). Results could not be reliably assessed or reported. | Posted | 3 months |
|
Study duration was approximately 6 months (3 months and 12 weeks) and a follow-up period of 15 days after the completion of treatment was included to assess safety information. Participants were assessed for adverse events for a total of 6.5 months.
The safety analysis set is a modified intent to treat population, defined as all subjects who received the respective treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibandronate | Ibandronate adverse events | 5 | 327 | 0 | 327 | ||
| EG001 | Risedronate | Risendronate adverse events | 3 | 327 | 0 | 327 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary Artery Disease | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Vitreous Haemorrhage | Eye disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
| |
| Malignant Hypertension | Vascular disorders | MedDRA 9.1 | Systematic Assessment |
|
Not provided
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-LaRoche | 800-821-8590 |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068296 | Risedronic Acid |
| D000077557 | Ibandronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| <0.0001 |
The reported p-values for the primary analysis test whether the overall preference rate for ibandronate equals 50%. Preference within each sequence is not tested. |
| No |
| Superiority or Other |
| Participants |
|
|
|
risedronate followed by ibandronate
|
risedronate followed by ibandronate
|