Post-Menopausal Osteoporosis
Conditions
Brief summary
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
DRUGIbandronate
150 mg orally once monthly for 6 months
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* post-menopausal women; * \>=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.
Exclusion criteria
* inability to stand or sit in an upright position for at least 60 minutes; * hypersensitivity to bisphosphonates; * treatment with other drugs affecting bone metabolism; * abnormalities of the oesophagus, which delay oesophageal emptying.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) | Visit 0 (less than or equal to [<=] Day -30) | The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication. |
| Percentage of Participants Who Reported Preference for Monthly Ibandronate | Visit 0 (<= Day -30) | Percentage of participants who reported preference for monthly ibandronate were reported. |
| Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Month 6 | Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B | Visit 0 (<= Day -30) | — |
| Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B | Baseline to Month 6 | — |
| Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Visit 0 (<= Day -30) | — |
| Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline, Month 6 | The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction. |
| Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B | Month 6 | — |
| Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | Month 6 | Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication |
| Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B | Up to Month 6 | — |
Countries
Albania, Bosnia and Herzegovina, Croatia, North Macedonia, Serbia, Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ibandronate Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study. | 670 |
| Total | 670 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event/intercurrent illness | 5 |
| Overall Study | Did not cooperate | 7 |
| Overall Study | Failure to return | 3 |
| Overall Study | Other protocol violation | 1 |
| Overall Study | Violation of selection criteria at entry | 8 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | Ibandronate |
|---|---|
| Age, Continuous | 62.7 years STANDARD_DEVIATION 8.9 |
| Sex: Female, Male Female | 670 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 640 |
| serious Total, serious adverse events | 6 / 640 |
Outcome results
Primary
Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ)
The CIQ was completed in Part A by all the participants. The information from the CIQ was used to determine the percentage of current daily or weekly bisphosphonate users for whom monthly ibandronate represented a potentially more satisfactory therapeutic option. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule. 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication. 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication.
Time frame: Visit 0 (less than or equal to [<=] Day -30)
Population: All enrolled participants who completed the part A of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibandronate | Percentage of Participants Current Daily or Weekly Bisphosphonate Users in Part A Who Answer 'Yes' to Any of the Questions in the Candidate Identification Questionnaire (CIQ) | 68.1 percentage of participants |
Primary
Percentage of Participants Who Reported Preference for Monthly Ibandronate
Percentage of participants who reported preference for monthly ibandronate were reported.
Time frame: Visit 0 (<= Day -30)
Population: All enrolled participants who completed the part A of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibandronate | Percentage of Participants Who Reported Preference for Monthly Ibandronate | 67.5 percentage of participants |
Primary
Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
Participants with a positive change from their baseline CSS at Month 6 are considered those participants who are satisfied with once-monthly dosing of ibandronate after 6 months of use were reported. The CSS is scaled from 0 to 100 and is an average of the 4 domain scores of the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q): Convenience (questions 1 to 6), Quality of Life (questions 7 and 8), Overall Satisfaction (questions 9 and 10) and Side Effects (questions 11 to 16). Higher scores indicating greater satisfaction.
Time frame: Month 6
Population: The intent-to treat (ITT) population included all participants who received at least one dose of study medication. Number of participant analyzed are with or without previous history of Fr.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate | Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Participants answer Yes with previous Fr (n=115) | 86.1 percentage of participants |
| Ibandronate | Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Participants answer Yes without previous Fr(n=310) | 89.0 percentage of participants |
| Ibandronate | Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Participants answer NO with previous Fr (n=47) | 87.2 percentage of participants |
| Ibandronate | Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group | Participants answer NO without previous Fr (n=155) | 77.4 percentage of participants |
Secondary
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B
The OPSAT-Q is a validated questionnaire designed to capture satisfaction with bisphosphonate treatment. It comprises four domains: convenience (questions 1-6), quality of life (questions 7 and 8), overall satisfaction (questions 9 and 10), and side effects (questions 11-16). Each domain (scale) ranges 0-100 scale. All items were scored such that higher scores represented greater satisfaction or less bother. Treatment satisfaction was measured with the OPSAT-Q composite satisfaction score (OPSAT-Q CSS), which was the average of the scores from the four domains of the OPSAT-Q converted to a 0-100-point scale, in which higher scores indicate greater satisfaction.
Time frame: Baseline, Month 6
Population: The ITT population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline: Convenience | 58.4 units on a scale | Standard Deviation 25.4 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Month 6: Convenience | 89.2 units on a scale | Standard Deviation 11.2 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline: Confidence with daily functioning | 62.6 units on a scale | Standard Deviation 25.6 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Month 6: Confidence with daily functioning | 86.6 units on a scale | Standard Deviation 14.8 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline: Overall satisfaction | 61.4 units on a scale | Standard Deviation 27 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Month 6: Overall satisfaction | 89.1 units on a scale | Standard Deviation 14.9 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Baseline: Side effects | 83.7 units on a scale | Standard Deviation 91.7 |
| Ibandronate | Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B | Month 6: Side effects | 93.2 units on a scale | Standard Deviation 14.2 |
Secondary
Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B
Time frame: Month 6
Population: Analysis was not performed because the data were difficult or impossible to derive from the database.
Secondary
Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ
Time frame: Visit 0 (<= Day -30)
Population: The ITT population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate | Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Answered Yes to at least 1 question in CIQ | 68.1 percentage of participants |
| Ibandronate | Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ | Answered NO to every question in CIQ | 31.9 percentage of participants |
Secondary
Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B
Time frame: Visit 0 (<= Day -30)
Population: The ITT population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibandronate | Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B | 99.4 percentage of participants |
Secondary
Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B
Time frame: Up to Month 6
Population: The ITT population included all participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ibandronate | Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B | 98.6 percentage of participants |
Secondary
Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B
Percentage of participants who report an improved satisfaction score after 6 months of monthly ibandronate therapy as compared to daily or weekly alendronate or risendronate at baseline based on responses to each individual question in the CIQ were reported. In the CIQ participants were asked to answer either 'yes' or 'no' to the following 3 questions: 1. I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule 2. More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication 3. Over the past 3 months, I have missed taking 3 or more doses of my current (daily or weekly) osteoporosis medication
Time frame: Month 6
Population: The ITT population included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ibandronate | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | CIQ Question 1 = No (n=205) | 80.0 percentage of participants |
| Ibandronate | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | CIQ Question 3 = No (n=530) | 83.8 percentage of participants |
| Ibandronate | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | CIQ Question 1 = Yes (n=422) | 88.2 percentage of participants |
| Ibandronate | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | CIQ Question 2 = Yes (n=115) | 93.0 percentage of participants |
| Ibandronate | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | CIQ Question 2 = No (n=512) | 83.8 percentage of participants |
| Ibandronate | Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B | CIQ Question 3 = Yes (n=97) | 94.8 percentage of participants |
Secondary
Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B
Time frame: Baseline to Month 6
Population: Analysis was not performed because the data were difficult or impossible to derive from the database.