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

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.

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 Investigator: Hoffmann-La Roche Industry

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD, PhD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on February 12, 2012

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