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

Completed · Phase 3

Conditions studied: Post Menopausal Osteoporosis

In brief

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.

Key facts

Study ID

NCT00048074

Run by

Hoffmann-La Roche

People needed

1395

Starts

2002-06-01

Expected to finish

2005-05-01

Last updated by the study team

2016-02-03

Who can join

Age: 55 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• women 55-80 years of age;
• post-menopausal for >=5 years;
• ambulatory.

You may not qualify if…

• 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.

Where it is running

• Study site — Irvine, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Leesburg, Florida, United States
• Study site — Gainesville, Georgia, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Bethesda, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Billings, Montana, United States
• Study site — Omaha, Nebraska, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Bismarck, North Dakota, United States
• Study site — Fargo, North Dakota, United States
• Study site — Wyomissing, Pennsylvania, United States
• Study site — Rapid City, South Dakota, United States
• Study site — San Antonio, Texas, United States
• Study site — Virginia Beach, Virginia, United States
• Study site — Madison, Wisconsin, United States
• Study site — Darlinghurst, Australia
• Study site — Melbourne, Australia
• Study site — Nedlands, Australia
• Study site — St Leonards, Australia
• Study site — Sydney, Australia
• Study site — Brussels, Belgium
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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