Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: Ibandronate (SB743830HD) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, PhD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Proportion(%) of patients who prefer the once-monthly dosing of ibandronate to the once-weekly dosing of risedronate.
Secondary outcome: 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
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
GSK Clinical Trials Call Center, Seoul 150-713, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 100-380, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 134-090, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 140-210, Korea, Republic of
GSK Clinical Trials Call Center, Daegu 700-721, Korea, Republic of
GSK Clinical Trials Call Center, Gwangju 501-757, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 138-736, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 135-710, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 110-744, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 133-792, Korea, Republic of
GSK Clinical Trials Call Center, Suwon 443-721, Korea, Republic of
GSK Clinical Trials Call Center, Daejeon 301-721, Korea, Republic of
GSK Clinical Trials Call Center, Seoul 120-752, Korea, Republic of
GSK Clinical Trials Call Center, Jeonju 561-712, Korea, Republic of
GSK Clinical Trials Call Center, Pusan 602-739, Korea, Republic of
Additional Information
Starting date: March 2007
Ending date: May 2008
Last updated: June 9, 2008
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