Status:
COMPLETED
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoporosis, Postmenopausal
Eligibility:
FEMALE
Phase:
PHASE4
Brief 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 do...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2008
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00405392
Start Date
March 22 2007
End Date
May 27 2008
Last Update
June 6 2018
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