A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Study Overview
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Brief Summary
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This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.

Official Title
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Open Label, Parallel Group, Multicenter Study of Two Intravenous (IV) Ibandronate Dose Regimens (2 mg Every 2 Months and 3 mg Every 3 Months) in Women With Postmenopausal Osteoporosis Who Completed Trial BM16550

Conditions
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Post-Menopausal Osteoporosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance Ambulatory Exclusion Criteria: Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study Malignant disease diagnosed since inclusion into previous study Treatment with drugs affecting bone metabolism since inclusion into previous study
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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).<br>|
| Active Comparator: 2<br> | Drug: ibandronate [Bonviva/Boniva]<br>* 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months | Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline,12, 24 and 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months | Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline,12, 24 and 36 months | 
| Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months | Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550) | 
| Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months | Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline. | Baseline, 6 months |