Trial · NCT00405392
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
NCT00405392, Phase 4, Completed, GlaxoSmithKline; results first posted 2018-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis. Trials, record NCT00405392. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405392
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
- NCT number
- NCT00405392
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 365 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Ibandronate (SB743830HD)
- First posted
- 2006-11-30
- Last updated
- 2018-06-06
- Results first posted
- 2018-06-06
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate | Visit 4 (Week 24) | 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. |
| Secondary | Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration | Visit 4 (Week 24) | 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. |
| 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 | Baseline (Week 0) and Visit 3 (Week 12) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate | Visit 4 (Week 24) | mITT population was comprised of any participant, who was randomly assigned, received the study drug once more at each phase, filled out the preference questionnaire at the completion of the study. Percentages do not sum to 100 because some participants did not express a preference. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration | Visit 4 (Week 24) | mITT Population. Percentages do not sum to 100 because some participants did not express a preference. | Percentage of particiants | NUMBER |
| 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 | Baseline (Week 0) and Visit 3 (Week 12) | Per protocol population comprised of any participant, who didn't violate the study protocol, filled the preference questionnaire at the completion of the study, finished assessment of bone turnover marker, and completed journal of GI symptoms. Only the participants available at the time of assessment were analyzed. | Percent change | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate | Ibandronate 150 mg Once Monthly | 62.42 | Percentage of participants | ||
| Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate | Risedronate 35 mg Once Weekly | 21.02 | Percentage of participants | ||
| Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration | Ibandronate 150 mg Once Monthly | 72.93 | Percentage of particiants | ||
| Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration | Risedronate 35 mg Once Weekly | 13.69 | Percentage of particiants | ||
| 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 | Ibandronate 150 mg Once Monthly | -57.23 | Standard Deviation 35.89 | Percent change | |
| 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 | Risedronate 35 mg Once Weekly | -56.95 | Standard Deviation 37.07 | Percent change |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sequence A: Ibandronate 150 mg Then Risedronate 35 mg | 183 | |
| Overall Study | STARTED | Sequence B: Risedronate 35 mg Then Ibandronate 150 mg | 182 | |
| Overall Study | COMPLETED | Sequence A: Ibandronate 150 mg Then Risedronate 35 mg | 153 | |
| Overall Study | COMPLETED | Sequence B: Risedronate 35 mg Then Ibandronate 150 mg | 155 | |
| Overall Study | NOT COMPLETED | Sequence A: Ibandronate 150 mg Then Risedronate 35 mg | 30 | |
| Overall Study | NOT COMPLETED | Sequence B: Risedronate 35 mg Then Ibandronate 150 mg | 27 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | Ibandronate 150 mg Once Monthly | 2 | 336 | |
| serious | Intervertebral Disc Disorder | Musculoskeletal and connective tissue disorders | Risedronate 35 mg Once Weekly | 0 | 334 | |
| serious | Varicose vein operation | Surgical and medical procedures | Ibandronate 150 mg Once Monthly | 1 | 336 | |
| serious | Varicose vein operation | Surgical and medical procedures | Risedronate 35 mg Once Weekly | 0 | 334 | |
| serious | Uterine prolapse | Reproductive system and breast disorders | Ibandronate 150 mg Once Monthly | 0 | 336 | |
| serious | Uterine prolapse | Reproductive system and breast disorders | Risedronate 35 mg Once Weekly | 1 | 334 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Ibandronate 150 mg Once Monthly | 1 | 336 | |
| serious | Back pain | Musculoskeletal and connective tissue disorders | Risedronate 35 mg Once Weekly | 0 | 334 | |
| serious | Aspergilloma | Infections and infestations | Ibandronate 150 mg Once Monthly | 1 | 336 | |
| serious | Aspergilloma | Infections and infestations | Risedronate 35 mg Once Weekly | 0 | 334 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibandronate 150 mg Once Monthly | 0 | 336 |
| Total, all-cause mortality | Risedronate 35 mg Once Weekly | 0 | 334 |
| Total, other adverse events | Ibandronate 150 mg Once Monthly | 0 | 0 |
| Total, other adverse events | Risedronate 35 mg Once Weekly | 0 | 0 |
| Total, serious adverse events | Ibandronate 150 mg Once Monthly | 6 | 336 |
| Total, serious adverse events | Risedronate 35 mg Once Weekly | 4 | 334 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ibandronate 150 mg Once Monthly vs Risedronate 35 mg Once Weekly: deaths from any cause | Trial comparisons |
| Ibandronate 150 mg Once Monthly vs Risedronate 35 mg Once Weekly: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00405392
GET https://conductscience.org/api/trials/v1/NCT00405392/registered