A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis
Phase 4
Completed
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Registration Number
- NCT02598440
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This study will evaluate participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 341
Inclusion Criteria
- Ambulatory women
- Diagnosis of post-menopausal osteoporosis
- Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry
Exclusion Criteria
- Inability to stand or sit in the upright position for greater than or equal to 60 minutes
- Allergy to bisphosphonates;
- Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group A: Ibandronate Then Alendronate Alendronate Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks. Group A: Ibandronate Then Alendronate Ibandronate Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks. Group B: Alendronate Then Ibandronate Ibandronate Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months. Group B: Alendronate Then Ibandronate Alendronate Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months.
- Primary Outcome Measures
Name Time Method Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate Up to 6 months
- Secondary Outcome Measures
Name Time Method Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate. Up to 6 months Incidence of adverse events Up to approximately 1 year