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A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
This study has been completed.
Study NCT00377234   Information provided by Hoffmann-La Roche
First Received: September 15, 2006   Last Updated: May 13, 2009   History of Changes

September 15, 2006
May 13, 2009
 
 
Proportion of patients preferring monthly dosing with Bonviva over weekly dosing with risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Proportion of patients preferring once monthly dosing with Boniva over once weekly dosing with risedronate
Complete list of historical versions of study NCT00377234 on ClinicalTrials.gov Archive Site
  • Convenience of monthly Bonviva over weekly risedronate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in serum CTX [ Time Frame: 12 weeks/3 months ] [ Designated as safety issue: No ]
  • Upper gastrointestinal symptoms [ Time Frame: 12 weeks/3 months ] [ Designated as safety issue: No ]
  • AEs and laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Convenience of monthly Boniva vs weekly risedronate; change in serum CTX at end of 1st treatment period; upper gastrointestinal symptoms during 1st treatment period. Safety: AEs, lab parameters
 
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Randomized, Open-Label, Multi-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once Monthly Ibandronate and Once Weekly Risedronate. A Six Month, Two-Sequence and Two-Period Crossover Study.

This 2 arm crossover study will evaluate patient reported preference for either once monthly Boniva (150mg p.o.) or once weekly risedronate (35mg p.o.). Patients with post-menopausal osteoporosis will be randomized to receive Boniva for 3 calendar months or risedronate for 12 weeks; they will then cross over to receive the alternative treatment for a further 12 weeks/3 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
356
August 2008
 

Inclusion Criteria:

  • ambulatory women with post-menopausal osteoporosis;
  • patients who are bisphosphonate-naive, or who have previously received oral daily or i.v. bisphosphonate therapy (fulfilling certain criteria detailed in the protocol).

Exclusion Criteria:

  • malignant disease diagnosed within previous 10 years (except for successfully resected basal cell cancer;) breast cancer within previous 20 years;
  • inability to stand or sit upright for at least 60 minutes;
  • disease/disorder/treatment with drugs known to influence bone metabolism.
Female
55 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00377234
Clinical Trials, Study Director, Hoffmann-La Roche
MA19547
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche, +1 973 235 5000
Hoffmann-La Roche
May 2009

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