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This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibandronate [Bonviva/Boniva] | Drug | 3 mg intravenously every 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline, Month 12 |
| Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline, Month 24 |
| Percent Change From Baseline in Mean Hip Bone BMD at Month 12 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline, Month 12 |
| Percent Change From Baseline in Mean Hip BMD at Month 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline, Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banja Luka | 78000 | Bosnia and Herzegovina | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Ibandronate | Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included participants who received at least 1 dose of study medication and at least 1 efficacy measurement was performed. One participant who was enrolled in the study initially, withdrew informed consent and was excluded from ITT population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ibandronate | Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 | Percent change was calculated as [(measure at time "t" minus [-] measure at baseline) divided by (/) measure at baseline] multiplied by (*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline. | ITT population. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 12 |
|
|
Baseline up to follow-up (Month 24)
ITT population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibandronate | Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fractures | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal 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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| Baseline, Month 12, Month 24 |
| Percent Change From Baseline in Total Hip T-score at Month 12 and 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis. | Baseline, Month 12, Month 24 |
| Percentage of Participants Who Received All Planned Study Medication (Compliance) | Baseline up to Month 12 |
| Correlation Coefficient of Participant's Profile With Compliance | Participant's profile included age, year since menopause, fracture history, and BMD at baseline. | Baseline up to Month 12 |
| Sarajevo |
| 71000 |
| Bosnia and Herzegovina |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
|
| Primary | Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline. | ITT population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 24 |
|
|
|
|
| Primary | Percent Change From Baseline in Mean Hip Bone BMD at Month 12 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline. | ITT population. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 12 |
|
|
|
|
| Primary | Percent Change From Baseline in Mean Hip BMD at Month 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline. | ITT population. Here "number of participants analyzed" included participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 24 |
|
|
|
|
| Secondary | Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis. | ITT population. Here "n" included participants who were evaluable at specified time point for the given arm. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 12, Month 24 |
|
|
|
|
| Secondary | Percent Change From Baseline in Total Hip T-score at Month 12 and 24 | Percent change was calculated as [(measure at time "t" - measure at baseline)/measure at baseline]*100, where t=12 and 24 months. The baseline value is used as a reference to calculate the relative change from baseline. T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis. A T-score below -2.5 in combination with a prevalent fracture indicates serious osteoporosis. | ITT population. Here "n" included participants who were evaluable at specified time point for the given arm. | Posted | Mean | Standard Deviation | percent change | Baseline, Month 12, Month 24 |
|
|
|
|
| Secondary | Percentage of Participants Who Received All Planned Study Medication (Compliance) | ITT population. | Posted | Number | percentage of participants | Baseline up to Month 12 |
|
|
|
| Secondary | Correlation Coefficient of Participant's Profile With Compliance | Participant's profile included age, year since menopause, fracture history, and BMD at baseline. | ITT population. | Posted | Number | correlation coefficient | Baseline up to Month 12 |
|
|
|
| 9 |
| 40 |
| 20 |
| 40 |
| Eyelid disorder | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Loss of conciousness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gallbladder disorder | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Flu like symptoms | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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.
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| <0.0005 |
Month 24: P-value for percent change from baseline was from a Wilcoxon signed rank test. |
| 2-Sided |
| No |
| Superiority or Other |
| 0.027 |
Month 24: P-value for percent change from baseline was from a paired samples t-test. |
| 2-Sided |
| No |
| Superiority or Other |