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

GlaxoSmithKline365 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

365

Conditions

Osteoporosis, Postmenopausal

Interventions

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate

Preference of monthly ibandronate and weekly risedronate was compared. Modified-intention-to-treat (mITT) population was used for analysis. Any participant randomly assigned, received the study drug, and participants were asked to fill the preference questionnaire on completion of study. Preference was calculated as percentage. Data for percentage of participants with preference to once-monthly dosing of ibandronate to the once-weekly dosing of risedronate was presented.

Time frame: Visit 4 (Week 24)

Secondary Outcomes

Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration

Participant's preference for convenient treatment was compared between monthly ibandronate and weekly risedronate. Analysis population was mITT. Preference for convenient treatment was calculated as percentage. Percentage of participants who think once-monthly ibandronate dosing is more convenient over once-weekly risedronate dosing were presented. Those participants who answered the two treatments equally convenient were excluded while reporting.

Time frame: Visit 4 (Week 24)

Mean Percent Change of Serum C-terminal Telopeptide (CTx) From Baseline to Visit 3 for Once-monthly Dosing of Ibandronate & Once-weekly Dosing of Risedronate

The difference of change in serum CTX from basal value between the two sequences was tested using ANCOVA at 95% confidence interval at 3 months (Visit 3) after the administration. Analysis was done with PP population. Baseline was value at Week 0, Change from baseline was calculated by subtracting Baseline value from value at specified time point.

Time frame: Baseline (Week 0) and Visit 3 (Week 12)