Postmenopausal Osteoporosis
Conditions
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.
Interventions
DRUGIbandronate
Film-coated oral ibandronate tablet (150 mg) once-monthly
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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: Percentage 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 |
| Part B: Number 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 eligible weekly biphosphonate users at screening who elect to enter Part B | Screening visit |
Countries
United States
Outcome results
None listed