Phase 4
Completed N=365
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT00405392 ↗
Enrolled (actual)
365
Serious AEs
1.5%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate — 62.42; 21.02 Percentage of participants — p=<0.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate |
62.42; 21.02 | <0.0001 sig |
| SECONDARY Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration |
72.93; 13.69 | <0.0001 sig |
| 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 |
-57.23; -56.95 | 0.9456 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00405392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.