A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

Study Overview
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Brief Summary
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This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.

Official Title
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A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Alendronate
* Drug: Ibandronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ambulatory women Diagnosis of post-menopausal osteoporosis Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry Exclusion Criteria: Inability to stand or sit in the upright position for greater than or equal to 60 minutes Allergy to bisphosphonates; Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: Ibandronate Then Alendronate<br>Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks. | Drug: Alendronate<br>* Participants wil receive once-weekly oral alendronate (70 mg tablet)<br>Drug: Ibandronate<br>* Participants wil receive once-monthly oral ibandronate (150 mg tablet)<br>* Other names: Bonviva;|
| Experimental: Group B: Alendronate Then Ibandronate<br>Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months. | Drug: Alendronate<br>* Participants wil receive once-weekly oral alendronate (70 mg tablet)<br>Drug: Ibandronate<br>* Participants wil receive once-monthly oral ibandronate (150 mg tablet)<br>* Other names: Bonviva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. |  | Up to 6 months | 
| Incidence of adverse events |  | Up to approximately 1 year |