NCT00545480

SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis.

A Randomized, Open-label Study to Investigate the Impact of Bone Marker Feedback on Persistence to Once Monthly Oral Bonviva (Ibandronate) Treatment for Post-menopausal Osteoporosis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will assess the impact of bone marker feedback, using blood sampling and communication of results at week 5, on persistence to monthly Bonviva (150mg po) in women with post-menopausal osteoporosis. The study will also assess safety, quality of life and patient satisfaction. All patients will receive Bonviva 150mg po monthly, and will be randomized into the bio-feedback or no bio-feedback study arms. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 12 months (with feedback)
DRUG	ibandronate [Bonviva/Boniva]	150mg po monthly for 12 months (without feedback)

Timeline

• Start date: 2006-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2007-10-17
• Last updated: 2015-08-18

Locations

190 sites across 1 country: France