Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

Phase 4

Completed

• Conditions: Osteoporosis, Postmenopausal

• Registration Number: NCT00405392
• Lead Sponsor: GlaxoSmithKline

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 Description

Not available

Study Timeline

• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Study Start: 2007-03-22
• Primary Completion: 2008-05-27
• Study Completion: 2008-05-27
• Status Verified: 2018-03
• Results First Submitted: 2018-03-15
• Results First Submitted QC: 2018-05-04
• Last Update Submitted: 2018-05-04
• Results First Posted: 2018-06-06
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 365

Inclusion Criteria

• Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score of -2.5 SD at spine or femur.
• Patients who have never received bisphosphonates therapy (bisphosphonates naive)

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Exclusion Criteria

• Inability to stand or sit in the upright position for at least 60 minutes;
• Hypersensitivity to any component of risedronate and ibandronate;
• Administration of any investigational drug within 30 days preceding the first dose of the study drug;
• Patient has been on hormone (estrogen) replacement therapy or other osteoporosis medication (e.g. SERMS and calcitonin) within the previous 3 months.
• Patient has been on systemic corticosteroids therapy for more than 1 month within the past year.
• Other bone disease except osteoporosis
• Current medical history of uncontrolled major upper GI disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration	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	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.