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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms of Ibandronate improve bone density in postmenopausal osteoporosis?
How does monthly Ibandronate compare to weekly Alendronate in treating postmenopausal osteopenia?
Which biomarkers predict response to Ibandronate in postmenopausal women with osteoporosis?
What are the adverse events associated with Ibandronate transition from Alendronate or Risedronate?
Are there combination therapies with Ibandronate for postmenopausal osteoporosis treatment?