A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Summary
This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2006-05
- Primary completion
- 2008-08
- Completion
- 2008-08
Outcome
Met primary endpoint
registry NUMBER Total: 79.9 percentage of participants NCT00377234 ↗
registry analysis (superiority or other test); Total; p <0.0001; Garts Test; note: Null hypothesis: Preference rate (including patients not expressing treatment preference and considering order treatments were received) for monthly ibandronate = 50%. NCT00377234 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ibandronate | Other / unclassified | 150 mg | — |
| Comparator | Risedronate | Small molecule | 35 mg | Oral |