A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis

Study Overview
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Brief Summary
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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.

Official Title
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Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice

Conditions
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Post Menopausal Osteoporosis

Intervention / Treatment
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* Drug: ibandronate [Bonviva/Boniva]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients, > 50 years of age Diagnosed osteoporosis Bone mineral density < minus 2.5 SD or osteoporotic fracture At least 3 years after menopause Exclusion Criteria: Impaired renal function Contra-indication to Calcium or Vitamin D therapy Previous or current treatment with biphosphonates

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 3 mg intravenously every 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |