BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00545779|
Recruitment Status : Completed
First Posted : October 17, 2007
Results First Posted : October 28, 2016
Last Update Posted : October 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Post-Menopausal Osteoporosis||Drug: Ibandronate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||677 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||'Open, Prospective, Multi-center, Two-part Study of Patient Preference With Monthly Ibandronate Therapy in Women With Postmenopausal Osteoporosis Switched From Once-daily or Once Weekly Alendronate or Risendronate - BONCURE (BONviva for Current Bisphosphonate Users - Regional European Trial)'|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
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.
150 mg orally once monthly for 6 months
Other Name: [Bonviva/Boniva]
- 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) [ Time Frame: 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:
- I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule.
- More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication.
- 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 [ Time Frame: 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 [ Time Frame: 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.
- 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) ]
- Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B [ Time Frame: 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:
- I would prefer a monthly oral dosing schedule to my current (daily or weekly) dosing schedule
- More than once per month, I have experienced stomach upset within 48 hours of taking my osteoporosis medication
- 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 [ Time Frame: Up to Month 6 ]
- Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B [ Time Frame: Visit 0 (<= Day -30) ]
- 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 ]
- 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 ]
- Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545779
|Bosnia and Herzegovina|
|Banja Luka, Bosnia and Herzegovina, 78000|
|Sarajevo, Bosnia and Herzegovina, 71 000|
|Sarajevo, Bosnia and Herzegovina, 71000|
|Tuzla, Bosnia and Herzegovina, 75000|
|Rijeka, Croatia, 51000|
|Slavonski Brod, Croatia, 35000|
|Split, Croatia, 21000|
|Zagreb, Croatia, 10000|
|Macedonia, The Former Yugoslav Republic of|
|Skopje, Macedonia, The Former Yugoslav Republic of|
|Belgrade, Serbia, 11000|
|Niska Banja, Serbia, 18205|
|Novi Sad, Serbia, 21000|
|Adana, Turkey, 01330|
|Ankara, Turkey, 06100|
|Ankara, Turkey, 06550|
|Antalya, Turkey, 07070|
|Aydin, Turkey, 09100|
|Bursa, Turkey, 16059|
|Denizli, Turkey, 20020|
|Erzurum, Turkey, 25240|
|Gaziantep, Turkey, 27310|
|Istanbul, Turkey, 34300|
|Istanbul, Turkey, 34303|
|Istanbul, Turkey, 35340|
|Istanbul, Turkey, 81190|
|Izmir, Turkey, 35100|
|Kayseri, Turkey, 38039|
|Konya, Turkey, 42080|
|Manisa, Turkey, 45200|
|Samsun, Turkey, 55139|
|Trabzon, Turkey, 61080|
|Study Director:||Clinical Trials||Hoffmann-La Roche|