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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


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


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


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

Page last updated: August 23, 2015

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