Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Osteoporosis
Intervention: Ibandronate (SB743830HD) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Additional Information
Starting date: March 2007
Last updated: January 17, 2012
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