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

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD)

Secondary outcome:

Relative change in mean lumbar spine BMD

Relative and absolute change in total hip, trochanter, femoral neck BMD

Percentage of responders

Change from baseline in fastin serum CTX

AEs, laboratory parameters

Minimum age: 55 Years. Maximum age: 80 Years. Gender(s): Female.

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.

MELBOURNE 3084, Australia

DARLINGHURST 2010, Australia

NEDLANDS 6000, Australia

SYDNEY 3129, Australia

ST. LEONARDS 2139, Australia

LIEGE 4020, Belgium

BRUXELLES 1180, Belgium

PRAHA 128 00, Czech Republic

PLZEN 305 99, Czech Republic

KØBENHAVN 1399, Denmark

BALLERUP 2750, Denmark

ÅRHUS 8000, Denmark

VEJLE 7100, Denmark

AALBORG 9000, Denmark

ORLEANS 45032, France

LYON 69000, France

BERLIN 12200, Germany

HAMBURG 20246, Germany

BOCHUM 44789, Germany

BUDAPEST 1036, Hungary

VALEGGIO SUL MINCIO 37067, Italy

ARENZANO 16011, Italy

SIENA 53100, Italy

MEXICO CITY 11000, Mexico

MONTERREY 64460, Mexico

STAVANGER 4010, Norway

HAUGESUND 5507, Norway

OSLO 0176, Norway

KRAKOW 30-510, Poland

KRAKOW 31-501, Poland

GRUDZIADZ 86-300, Poland

SOMMERSET WEST 7129, South Africa

CAPE TOWN 7500, South Africa

PRETORIA, South Africa

BARCELONA 08003, Spain

SANTANDER 39008, Spain

MADRID 28046, Spain

ABERDEEN AB25 1LD, United Kingdom

LITTLE ROCK, Arkansas 72205-7199, United States

GAINESVILLE, Georgia 30501, United States

BETHESDA, Maryland 20817, United States

ST LOUIS, Missouri 63110, United States

BILLINGS, Montana 59120, United States

OMAHA, Nebraska 68131, United States

ALBUQUERQUE, New Mexico 87106, United States

NEW YORK, New York 10029, United States

BISMARCK, North Dakota 58503, United States

FARGO, North Dakota 58103, United States

TORONTO, Ontario M5C 2T2, Canada

WYOMISSING, Pennsylvania 19610, United States

MONTREAL, Quebec H3A 1A1, Canada

MONTREAL, Quebec H2X 3J4, Canada

LAVAL, Quebec H7T 2P5, Canada

SASKATOON, Saskatchewan S7K 0H6, Canada

RAPID CITY, South Dakota 57701, United States

SAN ANTONIO, Texas 78229-4801, United States

VIRGINIA BEACH, Virginia 23462, United States

MADISON, Wisconsin 53792, United States

Ending date: December 2005
Last updated: June 17, 2008