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Trial record 23 of 30 for:    ( Map: Albania )

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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Post-Menopausal Osteoporosis
Intervention Drug: Ibandronate
Enrollment 677
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibandronate
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 677
Completed 633
Not Completed 44
Reason Not Completed
Violation of selection criteria at entry             8
Other protocol violation             1
Did not cooperate             7
Withdrawal by Subject             20
Adverse Event/intercurrent illness             5
Failure to return             3
Arm/Group Title Ibandronate
Hide Arm/Group Description 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 Number of Baseline Participants 670
Hide Baseline Analysis Population Description
Analysis population included all enrolled participants in Part A who provided the baseline information.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 670 participants
62.7  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 670 participants
Female
670
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title 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)
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who completed the part A of the study.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 677
Measure Type: Number
Unit of Measure: percentage of participants
68.1
2.Primary Outcome
Title Percentage of Participants Who Reported Preference for Monthly Ibandronate
Hide Description Percentage of participants who reported preference for monthly ibandronate were reported.
Time Frame Visit 0 (<= Day -30)
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants who completed the part A of the study.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 677
Measure Type: Number
Unit of Measure: percentage of participants
67.5
3.Primary Outcome
Title Percentage of Participants With Positive Change in Total Composite Satisfaction Score (CSS) at Month 6 in Part B by CIQ Fracture (Fr) Group
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 627
Measure Type: Number
Unit of Measure: percentage of participants
Participants answer Yes with previous Fr (n=115) 86.1
Participants answer Yes without previous Fr(n=310) 89.0
Participants answer NO with previous Fr (n=47) 87.2
Participants answer NO without previous Fr (n=155) 77.4
4.Secondary Outcome
Title Percentage of Participants Eligible Current Daily or Weekly Bisphosphonate Users at Screening Who Elect to Enter Part B by CIQ
Hide Description [Not Specified]
Time Frame Visit 0 (<= Day -30)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of study medication.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 645
Measure Type: Number
Unit of Measure: percentage of participants
Answered Yes to at least 1 question in CIQ 68.1
Answered NO to every question in CIQ 31.9
5.Secondary Outcome
Title Percentage of Participants Who Reported an Improved Satisfaction Score After 6 Months in Part B
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of study medication.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 645
Measure Type: Number
Unit of Measure: percentage of participants
CIQ Question 1 = Yes (n=422) 88.2
CIQ Question 1 = No (n=205) 80.0
CIQ Question 2 = Yes (n=115) 93.0
CIQ Question 2 = No (n=512) 83.8
CIQ Question 3 = Yes (n=97) 94.8
CIQ Question 3 = No (n=530) 83.8
6.Secondary Outcome
Title Percentage of Participants Who Have Greater Than or Equal to (>=) 80% Compliance With 6 Monthly Doses of Ibandronate in Part B
Hide Description [Not Specified]
Time Frame Up to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of study medication.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 645
Measure Type: Number
Unit of Measure: percentage of participants
98.6
7.Secondary Outcome
Title Percentage of Participants Who Choose a Monthly Reminder to Take Ibandronate in Part B
Hide Description [Not Specified]
Time Frame Visit 0 (<= Day -30)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of study medication.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 645
Measure Type: Number
Unit of Measure: percentage of participants
99.4
8.Secondary Outcome
Title Percentage of Participants Who Reported an Improvement in the Frequency of Gastro-intestinal (GI) Symptoms Per Month in Part B
Hide Description [Not Specified]
Time Frame Baseline to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed because the data were difficult or impossible to derive from the database.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Percentage of Participants by Age and Activity Level Reporting High Satisfaction According to the Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) in Part B
Hide Description [Not Specified]
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not performed because the data were difficult or impossible to derive from the database.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Osteoporosis Patient Satisfaction Questionnaire (OPSAT-Q) Domain Scores in Part B
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who received at least one dose of study medication.
Arm/Group Title Ibandronate
Hide Arm/Group Description:
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 Number of Participants Analyzed 645
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline: Convenience 58.4  (25.4)
Month 6: Convenience 89.2  (11.2)
Baseline: Confidence with daily functioning 62.6  (25.6)
Month 6: Confidence with daily functioning 86.6  (14.8)
Baseline: Overall satisfaction 61.4  (27.0)
Month 6: Overall satisfaction 89.1  (14.9)
Baseline: Side effects 83.7  (91.7)
Month 6: Side effects 93.2  (14.2)
Time Frame Baseline (Visit 1 of Part B) up to 15 days after the final visit (Month 6)
Adverse Event Reporting Description The Safety Population included 640 participants, who continued into Part B of the study and took at least one dose of study medication.
 
Arm/Group Title Ibandronate
Hide Arm/Group Description 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.
All-Cause Mortality
Ibandronate
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibandronate
Affected / at Risk (%)
Total   6/640 (0.94%) 
Cardiac disorders   
Pericarditis  1  1/640 (0.16%) 
Eye disorders   
Iridocyclitis  1  1/640 (0.16%) 
Gastrointestinal disorders   
Abdominal pain upper  1  1/640 (0.16%) 
Hiatus hernia  1  1/640 (0.16%) 
General disorders   
Pyrexia  1  1/640 (0.16%) 
Injury, poisoning and procedural complications   
Postoperative hernia  1  1/640 (0.16%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/640 (0.16%) 
Renal and urinary disorders   
Renal failure acute  1  1/640 (0.16%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/640 (0.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ibandronate
Affected / at Risk (%)
Total   18/640 (2.81%) 
Gastrointestinal disorders   
Dyspepsia  1  12/640 (1.88%) 
Nausea  1  7/640 (1.09%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545779     History of Changes
Other Study ID Numbers: ML20430
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: July 19, 2016
Results First Posted: October 28, 2016
Last Update Posted: October 28, 2016