Trial Outcomes & Findings for Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis (NCT NCT00405392)
NCT ID: NCT00405392
Last Updated: 2018-06-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
365 participants
Primary outcome timeframe
Visit 4 (Week 24)
Results posted on
2018-06-06
Participant Flow
A total of 365 korean female participants with postmenopausal osteoporosis were enrolled in this study, conducted for 6 months at 15 centers in South Korea.
A total of 365 participants were randomized in the study. Out of the randomized participants 13 were dropped out before administration of drug, remaining 352 participants were included in safety population, 314 participants were included in modified intent to treat population and 308 participants were included in the per-protocol population.
Participant milestones
| Measure |
Sequence A: Ibandronate 150 mg Then Risedronate 35 mg
Participants received treatment of ibandronate 150 milligram (mg) tablet orally once monthly for 3 months in period 1 and then administered risedronate 35 mg tablet orally once weekly for 12 weeks in period 2 in sequence A. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Sequence B: Risedronate 35 mg Then Ibandronate 150 mg
Participants received treatments of risedronate 35 mg tablet orally once weekly for 12 weeks in period 1 and then administered ibandronate 150 mg tablet orally once monthly for 3 months in period 2 in sequence B. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
|---|---|---|
|
Overall Study
STARTED
|
183
|
182
|
|
Overall Study
COMPLETED
|
153
|
155
|
|
Overall Study
NOT COMPLETED
|
30
|
27
|
Reasons for withdrawal
| Measure |
Sequence A: Ibandronate 150 mg Then Risedronate 35 mg
Participants received treatment of ibandronate 150 milligram (mg) tablet orally once monthly for 3 months in period 1 and then administered risedronate 35 mg tablet orally once weekly for 12 weeks in period 2 in sequence A. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Sequence B: Risedronate 35 mg Then Ibandronate 150 mg
Participants received treatments of risedronate 35 mg tablet orally once weekly for 12 weeks in period 1 and then administered ibandronate 150 mg tablet orally once monthly for 3 months in period 2 in sequence B. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
14
|
|
Overall Study
Did not meet Eligibility criteria
|
7
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Data missing
|
2
|
0
|
|
Overall Study
Non-compliance
|
0
|
1
|
|
Overall Study
Other
|
1
|
5
|
Baseline Characteristics
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis
Baseline characteristics by cohort
| Measure |
Sequence A: Ibandronate 150 mg Then Risedronate 35 mg
n=176 Participants
Participants received treatment of ibandronate 150 mg tablet orally once monthly for 3 months in period 1 and then administered risedronate 35 mg tablet orally once weekly for 12 weeks in period 2 in sequence A. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Sequence B: Risedronate 35 mg Then Ibandronate 150 mg
n=176 Participants
Participants received treatments of risedronate 35 mg tablet orally once weekly for 12 weeks in period 1 and then administered ibandronate 150 mg tablet orally once monthly for 3 months in period 2 in sequence B. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month) and on the same day every week in case of the once-weekly drug (e.g. every Sunday). The two drugs were administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Total
n=352 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.33 Years
STANDARD_DEVIATION 6.53 • n=5 Participants
|
61.99 Years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
61.66 Years
STANDARD_DEVIATION 6.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
176 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
352 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 4 (Week 24)Population: 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.
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.
Outcome measures
| Measure |
Ibandronate 150 mg Once Monthly
n=314 Participants
Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Risedronate 35 mg Once Weekly
n=314 Participants
Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
|---|---|---|
|
Percentage of Participants Who Prefer the Once-monthly Dosing of Ibandronate to the Once-weekly Dosing of Risedronate
|
62.42 Percentage of participants
|
21.02 Percentage of participants
|
SECONDARY outcome
Timeframe: Visit 4 (Week 24)Population: mITT Population. Percentages do not sum to 100 because some participants did not express a preference.
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.
Outcome measures
| Measure |
Ibandronate 150 mg Once Monthly
n=314 Participants
Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Risedronate 35 mg Once Weekly
n=314 Participants
Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
|---|---|---|
|
Percentage of Participants Choosing Ibandronate or Risedronate as Their Preferred Treatment Based on Convenience of Administration
|
72.93 Percentage of particiants
|
13.69 Percentage of particiants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) and Visit 3 (Week 12)Population: 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.
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.
Outcome measures
| Measure |
Ibandronate 150 mg Once Monthly
n=153 Participants
Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Risedronate 35 mg Once Weekly
n=154 Participants
Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
|---|---|---|
|
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 Percent change
Standard Deviation 35.89
|
-56.95 Percent change
Standard Deviation 37.07
|
Adverse Events
Ibandronate 150 mg Once Monthly
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Risedronate 35 mg Once Weekly
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibandronate 150 mg Once Monthly
n=336 participants at risk
Participants received ibandronate 150 mg tablet orally once in a month for 3 months either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
Risedronate 35 mg Once Weekly
n=334 participants at risk
Participants received risedronate 35 mg tablet orally once weekly for 12 weeks either in period 1 or period 2 as per the randomization sequence. Participants were recommended to take the tablet on the same day every month in case of the once-monthly drug (e.g. on the 15th each month). The treatment was administered on an empty stomach in the morning, followed by an overnight fast (at least 6-hour fast).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.60%
2/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.00%
0/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Surgical and medical procedures
Varicose vein operation
|
0.30%
1/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.00%
0/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.30%
1/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.30%
1/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.00%
0/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Infections and infestations
Aspergilloma
|
0.30%
1/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.00%
0/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.60%
2/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Endocrine disorders
Papillary thyroid cancer
|
0.30%
1/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.00%
0/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/336 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
0.30%
1/334 • Up to 6 months
Safety population was used to analyze adverse events and all-cause mortality. Datasets could not be located to generate separate non-serious adverse event table.
|
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER