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

• Status: Completed
• Trial end date: 2008-05-27
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline; Hoffmann-La Roche
• Treatments: Diphosphonates; Ibandronic Acid; Risedronate Sodium

Criteria

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