A Study of Ibandronate (Boniva) to Evaluate Satisfaction in Women With Post-Menopausal Osteoporosis or Osteopenia
- Registration Number
- NCT02604836
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1711
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ibandronate Ibandronate Participants will receive 150 milligrams (mg) of ibandronate as a film-coated tablet once-monthly.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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