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BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
This study is ongoing, but not recruiting participants.
Study NCT00545779   Information provided by Hoffmann-La Roche
First Received: October 16, 2007   Last Updated: September 16, 2009   History of Changes

October 16, 2007
September 16, 2009
December 2006
 
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 ]
Number and proportion of patients who report preference for either monthly Bonviva, or daily or weekly alendronate or risedronate.
Complete list of historical versions of study NCT00545779 on ClinicalTrials.gov Archive Site
  • Improved satisfaction scores with Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • >=80% compliance with Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Choice of monthly reminders to take Bonviva [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in GI symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
 
BONCURE Study: A Study of Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis on Bisphosphonate Therapy.
'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.'

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.

 
Phase IV
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Post-Menopausal Osteoporosis
Drug: ibandronate [Bonviva/Boniva]
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
650
October 2008
 

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.
Female
 
No
Contact information is only displayed when the study is recruiting subjects
Albania,   Bosnia and Herzegovina,   Croatia,   Macedonia, The Former Yugoslav Republic of,   Serbia,   Turkey
 
NCT00545779
Clinical Trials, Study Director, Hoffmann-La Roche
ML20430
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
Hoffmann-La Roche
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP