Trial Outcomes & Findings for BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. (NCT NCT00545779)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

677 participants

Primary outcome timeframe

Visit 0 (less than or equal to [<=] Day -30)

Results posted on

2016-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	677
Overall Study COMPLETED	633
Overall Study NOT COMPLETED	44

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Violation of selection criteria at entry	8
Overall Study Other protocol violation	1
Overall Study Did not cooperate	7
Overall Study Withdrawal by Subject	20
Overall Study Adverse Event/intercurrent illness	5
Overall Study Failure to return	3

Baseline Characteristics

BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibandronate n=670 Participants 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.
Age, Continuous	62.7 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	670 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 0 (less than or equal to [<=] Day -30)

Population: All enrolled participants who completed the part A of the study.

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.

Outcome measures

Outcome measures
Measure	Ibandronate n=677 Participants 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.
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 outcome

Timeframe: Visit 0 (<= Day -30)

Population: All enrolled participants who completed the part A of the study.

Percentage of participants who reported preference for monthly ibandronate were reported.

Outcome measures

Outcome measures
Measure	Ibandronate n=677 Participants 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.
Percentage of Participants Who Reported Preference for Monthly Ibandronate	67.5 percentage of participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Ibandronate n=627 Participants 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.
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
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
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
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 outcome

Timeframe: Visit 0 (<= Day -30)

Population: The ITT population included all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Ibandronate n=645 Participants 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.
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
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 outcome

Timeframe: Month 6

Population: The ITT population included all participants who received at least one dose of study medication.

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

Outcome measures

Outcome measures
Measure	Ibandronate n=645 Participants 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.
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
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
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
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
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
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

SECONDARY outcome

Timeframe: Up to Month 6

Population: The ITT population included all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Ibandronate n=645 Participants 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.
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 outcome

Timeframe: Visit 0 (<= Day -30)

Population: The ITT population included all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Ibandronate n=645 Participants 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.
Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B	99.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Analysis was not performed because the data were difficult or impossible to derive from the database.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Population: Analysis was not performed because the data were difficult or impossible to derive from the database.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: The ITT population included all participants who received at least one dose of study medication.

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.

Outcome measures

Outcome measures
Measure	Ibandronate n=645 Participants 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.
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
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B Baseline: Convenience	58.4 units on a scale Standard Deviation 25.4
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B Month 6: Convenience	89.2 units on a scale Standard Deviation 11.2
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
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
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B Baseline: Overall satisfaction	61.4 units on a scale Standard Deviation 27.0
Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B Baseline: Side effects	83.7 units on a scale Standard Deviation 91.7
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

Adverse Events

Ibandronate

Serious events: 6 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ibandronate n=640 participants at risk 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.
Cardiac disorders Pericarditis	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Eye disorders Iridocyclitis	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Gastrointestinal disorders Abdominal pain upper	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Gastrointestinal disorders Hiatus hernia	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
General disorders Pyrexia	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Injury, poisoning and procedural complications Postoperative hernia	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Musculoskeletal and connective tissue disorders Bone pain	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Renal and urinary disorders Renal failure acute	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.16% 1/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.

Other adverse events

Other adverse events
Measure	Ibandronate n=640 participants at risk 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.
Gastrointestinal disorders Dyspepsia	1.9% 12/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
Gastrointestinal disorders Nausea	1.1% 7/640 • Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6) The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER