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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Ibandronate (SB743830HD)

Primary Measures

• Proportion(%) of patients who prefer the once-monthly dosing of ibandronate to the once-weekly dosing of risedronate.

Secondary Measures

• 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

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)

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD, PhD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405392

Study ID Number: 109393

ClinicalTrials.gov Identifier: NCT00405392

Health Authority: Korea: Food and Drug Administration