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BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
This study has been completed.
Study NCT00545909   Information provided by Hoffmann-La Roche
First Received: October 16, 2007   Last Updated: May 13, 2009   History of Changes

October 16, 2007
May 13, 2009
 
 
Comparison of percentage of patients with >=83% adherence to Bonviva in feedback vs no feedback group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparison of the proportion of patients with >=83% adherence at 6 months (ie 5 of 6 possible administrations)to Bonviva in the feedback vs no feedback group.
Complete list of historical versions of study NCT00545909 on ClinicalTrials.gov Archive Site
  • Patient satisfaction by OPSAT-Q and OPPS. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Tolerability; SAEs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Compliance: Patient satisfaction at 6 months by OPSAT-Q and OPPS. Safety: Tolerability, SAEs
 
BEATRIS Study: A Study of Adherence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis
A Randomised, Open Label Study to Investigate the Impact of Bone Marker Feedback at 2 Months on Adherence to Monthly Oral Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis.

This 2 arm study will assess the impact of Bone Marker Feedback (BMF), using blood sampling and communication of the results at 2 months, on adherence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. Patients will be randomized into either 1) a group which receives bone marker feedback or 2)a group which does not receive feedback on the results. The study will also assess patient satisfaction with treatment with once monthly Bonviva. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Parallel 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.
 
Completed
585
August 2008
 

Inclusion Criteria:

  • ambulatory post-menopausal women with osteoporosis;
  • 55-85 years of age;
  • eligible for bisphosphonate treatment;
  • naive to bisphosphonate therapy, or lapsed users (last bisphosphonate intake > 6 months ago).

Exclusion Criteria:

  • inability to stand or sit in an upright position for at least 60 minutes;
  • inability to swallow a tablet whole;
  • hypersensitivity to bisphosphonates;
  • administration of any drug, or presence of active disease, known to influence bone metabolism;
  • uncorrected hypocalcemia or other bone disturbances of bone and mineral metabolism;
  • history of major upper gastrointestinal disease.
Female
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Greece,   Ireland,   Luxembourg
 
NCT00545909
Clinical Trials, Study Director, Hoffmann-La Roche
ML19913
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