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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: Ibandronate (SB743830HD)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00405392

109393

Details and patient eligibility

About

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.

Enrollment

365 patients

Sex

Female

Volunteers

No Healthy Volunteers

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