BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Study Overview
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Brief Summary
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This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
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'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphosphonate Users - Regional European Trial)'

Conditions
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Post-Menopausal Osteoporosis

Intervention / Treatment
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* Drug: Ibandronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: post-menopausal women; >=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis. Exclusion Criteria: inability to stand or sit in an upright position for at least 60 minutes; hypersensitivity to bisphosphonates; treatment with other drugs affecting bone metabolism; abnormalities of the oesophagus, which delay oesophageal emptying.
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibandronate<br>Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study. | Drug: Ibandronate<br>* 150 mg orally once monthly for 6 months<br>* Other names: [Bonviva/Boniva];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) | The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication. | Visit 0 (less than or equal to [<=] Day -30) | 
| Percentage of Participants Who Reported Preference for Monthly Ibandronate | Percentage of participants who reported preference for monthly ibandronate were reported. | Visit 0 (<= Day -30) | 
| Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ |  | Visit 0 (<= Day -30) | 
| Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication | Month 6 | 
| Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B |  | Up to Month 6 | 
| Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B |  | Visit 0 (<= Day -30) | 
| Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B |  | Baseline to Month 6 | 
| Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B |  | Month 6 | 
| Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction. | Baseline, Month 6 |