Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-22

Study Completion Date

2008-05-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Ibandronate (SB743830HD)

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No