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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00048074

Purpose

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.

Condition	Intervention	Phase
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva]	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Menopause Minerals Osteoporosis

Drug Information available for: Ibandronic acid Ibandronate sodium

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Relative change (%) from baseline in mean lumbar spine bone mineral density (BMD) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relative change in mean lumbar spine BMD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Relative and absolute change in total hip, trochanter, femoral neck BMD [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
Change from baseline in fastin serum CTX [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	1395
Study Completion Date:	December 2005

Arms	Assigned Interventions
1: Experimental	Drug: ibandronate [Bonviva/Boniva] 2mg iv every 2 months
2: Experimental	Drug: ibandronate [Bonviva/Boniva] 2.5mg po daily
3: Experimental	Drug: ibandronate [Bonviva/Boniva] 3mg iv every 3 months
4: Active Comparator	Drug: ibandronate [Bonviva/Boniva] 2.5mg po daily

Eligibility

Ages Eligible for Study:	55 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048074

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Locations

United States, Arkansas

LITTLE ROCK, Arkansas, United States, 72205-7199
United States, California

IRVINE, California, United States, 92618

RANCHO MIRAGE, California, United States, 92270
United States, Florida

LEESBURG, Florida, United States, 34748
United States, Georgia

GAINESVILLE, Georgia, United States, 30501
United States, Idaho

COEUR D'ALENE, Idaho, United States, 83814
United States, Maryland

BETHESDA, Maryland, United States, 20817
United States, Missouri

ST LOUIS, Missouri, United States, 63110
United States, Montana

BILLINGS, Montana, United States, 59120
United States, Nebraska

OMAHA, Nebraska, United States, 68131
United States, New Mexico

ALBUQUERQUE, New Mexico, United States, 87106
United States, New York

NEW YORK, New York, United States, 10029
United States, North Dakota

BISMARCK, North Dakota, United States, 58503

FARGO, North Dakota, United States, 58103
United States, Pennsylvania

WYOMISSING, Pennsylvania, United States, 19610
United States, South Dakota

RAPID CITY, South Dakota, United States, 57701
United States, Texas

SAN ANTONIO, Texas, United States, 78229-4801
United States, Virginia

VIRGINIA BEACH, Virginia, United States, 23462
United States, Wisconsin

MADISON, Wisconsin, United States, 53792
Australia

MELBOURNE, Australia, 3084

ST. LEONARDS, Australia, 2139

NEDLANDS, Australia, 6000

SYDNEY, Australia, 3129

DARLINGHURST, Australia, 2010
Belgium

LIEGE, Belgium, 4020

BRUXELLES, Belgium, 1180
Canada, Ontario

TORONTO, Ontario, Canada, M5C 2T2
Canada, Quebec

MONTREAL, Quebec, Canada, H3A 1A1

MONTREAL, Quebec, Canada, H2X 3J4

LAVAL, Quebec, Canada, H7T 2P5
Canada, Saskatchewan

SASKATOON, Saskatchewan, Canada, S7K 0H6
Czech Republic

PRAHA, Czech Republic, 128 00

PLZEN, Czech Republic, 305 99
Denmark

KØBENHAVN, Denmark, 1399

BALLERUP, Denmark, 2750

ÅRHUS, Denmark, 8000

VEJLE, Denmark, 7100

AALBORG, Denmark, 9000
France

ORLEANS, France, 45032

LYON, France, 69000
Germany

BERLIN, Germany, 12200

HAMBURG, Germany, 20246

BOCHUM, Germany, 44789
Hungary

BUDAPEST, Hungary, 1036
Italy

VALEGGIO SUL MINCIO, Italy, 37067

ARENZANO, Italy, 16011

SIENA, Italy, 53100
Mexico

MEXICO CITY, Mexico, 11000

MONTERREY, Mexico, 64460
Norway

STAVANGER, Norway, 4010

HAUGESUND, Norway, 5507

OSLO, Norway, 0176
Poland

KRAKOW, Poland, 30-510

KRAKOW, Poland, 31-501

GRUDZIADZ, Poland, 86-300
South Africa

SOMMERSET WEST, South Africa, 7129

CAPE TOWN, South Africa, 7500

PRETORIA, South Africa
Spain

BARCELONA, Spain, 08003

SANTANDER, Spain, 39008

MADRID, Spain, 28046
United Kingdom

ABERDEEN, United Kingdom, AB25 1LD

NEWCASTLE UPON TYNE, United Kingdom, NE7 7DN

MANCHESTER, United Kingdom, M13 9WL

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BM16550
Study First Received:	October 24, 2002
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00048074 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Ibandronic acid
Musculoskeletal Diseases
Physiological Effects of Drugs
Osteoporosis, Postmenopausal
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009