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
Results First Posted : June 6, 2018
Last Update Posted : June 6, 2018
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|
|Osteoporosis, Postmenopausal||Drug: Ibandronate (SB743830HD)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||365 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|
|Actual Study Start Date :||March 22, 2007|
|Actual Primary Completion Date :||May 27, 2008|
|Actual Study Completion Date :||May 27, 2008|
- Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate [ Time Frame: Visit 4 (Week 24) ]Preference of monthly ibandronate and weekly risedronate was compared. Modified-intention-to-treat (mITT) population was used for analysis. Any participant randomly assigned, received the study drug, and participants were asked to fill the preference questionnaire on completion of study. Preference was calculated as percentage. Data for percentage of participants with preference to once-monthly dosing of ibandronate to the once-weekly dosing of risedronate was presented.
- Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration [ Time Frame: Visit 4 (Week 24) ]Participant's preference for convenient treatment was compared between monthly ibandronate and weekly risedronate. Analysis population was mITT. Preference for convenient treatment was calculated as percentage. Percentage of participants who think once-monthly ibandronate dosing is more convenient over once-weekly risedronate dosing were presented. Those participants who answered the two treatments equally convenient were excluded while reporting.
- Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate [ Time Frame: Baseline (Week 0) and Visit 3 (Week 12) ]The difference of change in serum CTX from basal value between the two sequences was tested using ANCOVA at 95% confidence interval at 3 months (Visit 3) after the administration. Analysis was done with PP population. Baseline was value at Week 0, Change from baseline was calculated by subtracting Baseline value from value at specified time point.
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||GlaxoSmithKline|