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
Overview
- Phase
- Phase 4
- Intervention
- Ibandronate
- Conditions
- Postmenopausal Osteoporosis
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 1711
- Primary Endpoint
- Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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).
Arms & Interventions
Ibandronate
Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.
Intervention: Ibandronate
Outcomes
Primary Outcomes
Part A: Number of participants who currently use weekly biphosphonate who answer "yes" to any of the questions in Candidate Identification Questionnaire (CIQ)
Time Frame: 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
Time Frame: 6 months
Part B: Percentage of participants who demonstrate improvement from their baseline satisfaction score after 6 months of ibandronate
Time Frame: 6 months
Secondary Outcomes
- 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 eligible weekly biphosphonate users at screening who elect to enter Part B(Screening visit)
- 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)