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

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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.


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.
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