|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 16, 2007 | ||||
| Last Updated Date | September 16, 2009 | ||||
| Start Date ICMJE | December 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Number and percentage of patients who prefer monthly Bonviva, compared with previous daily or weekly alendronate or risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Number and proportion of patients who report preference for either monthly Bonviva, or daily or weekly alendronate or risedronate. | ||||
| Change History | Complete list of historical versions of study NCT00545779 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
Efficacy: Improved satisfaction score after 6 months of Bonviva; >=80% compliance with 6 monthly doses of Bonviva; choice of monthly reminder to take Bonviva; improvement in GI symptoms. Safety: AEs, laboratory parameters. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy. | ||||
| Official Title ICMJE | 'An Open-label Study of Patient Preference With Monthly Bonviva Therapy in Women With Post-menopausal Osteoporosis Switched From Daily or Weekly Alendronate or Risendronate.' | ||||
| Brief Summary | This single arm study will assess patient preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Patients currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify patients who may benefit from a monthly Bonviva regimen. Eligible patients will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg po. At the beginning and end of Bonviva treatment, all patients 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. |
||||
| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Post-Menopausal Osteoporosis | ||||
| Intervention ICMJE | Drug: ibandronate [Bonviva/Boniva] | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 650 | ||||
| Estimated Completion Date | October 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Albania, Bosnia and Herzegovina, Croatia, Macedonia, The Former Yugoslav Republic of, Serbia, Turkey | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00545779 | ||||
| Responsible Party | Clinical Trials, Study Director, Hoffmann-La Roche | ||||
| Study ID Numbers ICMJE | ML20430 | ||||
| Study Sponsor ICMJE | Hoffmann-La Roche | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Hoffmann-La Roche | ||||
| Verification Date | September 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||