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

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.

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