Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
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|ClinicalTrials.gov Identifier: NCT00405392|
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : October 4, 2016
This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate.
Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen.
Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa.
After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.
|Condition or disease||Intervention/treatment||Phase|
|Postmenopausal Osteoporosis||Drug: Ibandronate (SB743830HD)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||364 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-centre, Randomized Study to Investigate Patient Preference on Dosing in the Once-monthly Ibandronate and the Once-weekly Risedronate in Korean Women With Postmenopausal Osteoporosis. A Six-month, Two-sequence, and Two Period Crossover Study|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2008|
|Actual Study Completion Date :||May 2008|
- Proportion(%) of patients who prefer the once-monthly dosing of ibandronate to the once-weekly dosing of risedronate.
- Percentage of patients who think once-monthly ibandronate dosing is more convenient vs once-weekly risedronate dosing Mean percent change of serum CTx from baseline to visit3 for once-monthly dosing of ibandronate & once-weekly dosing of risedronate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405392
|Study Director:||GSK Clinical Trials, MD, PhD||GlaxoSmithKline|