A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia

Study Overview
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Brief Summary
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This study will investigate participant satisfaction (including compliance, preference, tolerability) with once-monthly Bonviva in women with post-menopausal osteoporosis or osteopenia transitioned from once-weekly alendronate or risedronate. The anticipated time on study treatment is 6 months, and the target sample size is 1776 individuals.

Official Title
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A Prospective, Open-Label, Multi-Center, Two-Part Study to Investigate Patient Satisfaction With Monthly Dosed Ibandronate Therapy in Women With Post-Menopausal Osteoporosis or Osteopenia Transitioned From Once-Weekly Alendronate or Risendronate

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Ibandronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Women who had been receiving once-weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis for greater than or equal to (>=) 3 months Exclusion Criteria: Inability to stand or sit upright for >=60 minutes Hypersensitivity to bisphosphonates Inability to swallow a tablet whole Malignant disease diagnosed within previous 10 years (except resected basal cell cancer).
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: Ibandronate<br>Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly. | Drug: Ibandronate<br>* Film-coated oral ibandronate tablet (150 mg) once-monthly<br>* Other names: Bonviva/Boniva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Number of participants who currently use weekly biphosphonate who answer yes to any of the questions in Candidate Identification Questionnaire (CIQ) |  | Up to 30 days prior to baseline visit | 
| Part B: Number of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate |  | 6 months | 
| Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part B: Percentage of eligible weekly biphosphonate users at screening who elect to enter Part B |  | Screening visit | 
| Part B: Percentage of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate |  | 6 months | 
| Part B: Percentage of participants who report preference to monthly ibandronate or weekly alendronate or risedronate |  | 6 months | 
| Part B: Percentage of participants who have greater than or equal to (>=) 80 percent (%) compliance |  | 6 months | 
| Part B: Percentage of participants who report an improvement in the gastrointestinal (GI) symptoms |  | 6 months | 
| Part B: Percentage of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) |  | 6 months | 
| Part B: Individual Domain scores from Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) |  | Baseline and 6 months | 
| Part B: Number of eligible weekly biphosphonate users at screening who elect to enter Part B |  | Screening Visit | 
| Part B: Number of participants who report an improved satisfaction score with monthly ibandronate compared to weekly alendronate or risendronate |  | 6 months | 
| Part B: Number of participants who report preference to monthly ibandronate or weekly alendronate or risedronate |  | 6 months | 
| Part B: Number of participants who have >= 80% compliance |  | 6 months | 
| Part B: Number of participants who report an improvement in the GI symptoms |  | 6 months | 
| Part B: Number of participants by age and activity level who report high satisfaction according to Osteoporosis Patient Survey satisfaction Questionnaire (OPSAT-Q) |  | 6 months |