A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Osteoporosis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 55 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | May 2006 |
| End Date: | August 2008 |
Randomized, Open-label, Multi-center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-sequence and Two-period Crossover Study.
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.
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.
Inclusion Criteria:
- ambulatory women with post-menopausal osteoporosis;
- patients who are bisphosphonate-naive, or who have previously received oral daily or
i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).
Exclusion Criteria:
- malignant disease diagnosed within previous 10 years (except for successfully
resected basal cell cancer;) breast cancer within previous 20 years;
- inability to stand or sit upright for at least 60 minutes;
- disease/disorder/treatment with drugs known to influence bone metabolism.
We found this trial at
45
sites
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