NCT00048074

DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis

A Randomized, Double-blind Study Comparing the Effect of Different Treatment Regimens of Intravenous Bonviva on Lumbar Bone Mineral Density in Women With Osteoporosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,395 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.

Conditions

• Post Menopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	ibandronate [Bonviva/Boniva]	2mg iv every 2 months
DRUG	ibandronate [Bonviva/Boniva]	2.5mg po daily
DRUG	ibandronate [Bonviva/Boniva]	3mg iv every 3 months

Timeline

• Start date: 2002-06-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2002-10-25
• Last updated: 2016-02-03
• Results posted: 2016-02-03

Locations

64 sites across 16 countries: United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Hungary, Italy, Mexico, Norway, Poland, South Africa, Spain, United Kingdom