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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Diphosphonates; Ibandronic Acid

Criteria

Inclusion Criteria:

• women 55-80 years of age;

• post-menopausal for >=5 years;

• ambulatory.

Exclusion Criteria:

• malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);

• breast cancer within the previous 20 years;

• allergy to bisphosphonates;

• previous treatment with an intravenous bisphosphonate at any time;

• previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.