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

Status:	Completed
Conditions:	Osteoporosis, Osteoporosis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	55 - 80
Updated:	4/21/2016
Start Date:	June 2002
End Date:	May 2005

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

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.

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.

We found this trial at

sites

Clinical Trial Facility in Irvine California

Irvine, California 92697

1152

from

Irvine, CA