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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00405392 |
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.
Condition | Intervention | Phase |
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Postmenopausal Osteoporosis |
Drug: Ibandronate (SB743830HD) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 364 |
Study Start Date: | March 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109393, ML20293 |
Study First Received: | November 29, 2006 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00405392 |
Health Authority: | Korea: Food and Drug Administration |
Ibandronate risedronate Osteoporosis preference |
Calcium, Dietary Ibandronic acid Musculoskeletal Diseases Osteoporosis, Postmenopausal |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Risedronic acid |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Calcium Channel Blockers Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions |