Clinical Trial: Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Pos
Brief Summary:
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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Proportion(%) of patients who prefer the once-monthly dosing of ibandronate to the once-weekly dosing of risedronate.
Original Primary Outcome: Same as current
Current Secondary Outcome: 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
Original Secondary Outcome:
- 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
Information By: Hoffmann-La Roche
Dates:
Date Received: November 29, 2006
Date Started: March 2007
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2010
