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

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405392
• Other study ID #: 109393
• Status: Completed
• Phase: Phase 4
• Start date: March 22, 2007
• Est. completion date: May 27, 2008

Study information

• Verified date: March 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: May 27, 2008
• Est. primary completion date: May 27, 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Ibandronate (SB743830HD)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visit 4 (Week 24)
Secondary	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.	Visit 4 (Week 24)
Secondary	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.	Baseline (Week 0) and Visit 3 (Week 12)