DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis
NCT ID: NCT00048074
Last Updated: 2016-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1395 participants
INTERVENTIONAL
2002-06-30
2005-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
oral placebo daily and IV ibandronate 2 mg q 2 mo
ibandronate [Bonviva/Boniva]
2mg iv every 2 months
2
oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo
ibandronate [Bonviva/Boniva]
2.5mg po daily
3
oral placebo daily and IV ibandronate 3 mg q 3 mo
ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Interventions
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ibandronate [Bonviva/Boniva]
2mg iv every 2 months
ibandronate [Bonviva/Boniva]
2.5mg po daily
ibandronate [Bonviva/Boniva]
3mg iv every 3 months
Eligibility Criteria
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Inclusion Criteria
* post-menopausal for \>=5 years;
* ambulatory.
Exclusion Criteria
* 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.
55 Years
80 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Little Rock, Arkansas, United States
Irvine, California, United States
Rancho Mirage, California, United States
Leesburg, Florida, United States
Gainesville, Georgia, United States
Coeur d'Alene, Idaho, United States
Bethesda, Maryland, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Wyomissing, Pennsylvania, United States
Rapid City, South Dakota, United States
San Antonio, Texas, United States
Virginia Beach, Virginia, United States
Madison, Wisconsin, United States
Darlinghurst, , Australia
Melbourne, , Australia
Nedlands, , Australia
St Leonards, , Australia
Sydney, , Australia
Brussels, , Belgium
Liège, , Belgium
Toronto, Ontario, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Pilsen, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Aarhus, , Denmark
Ballerup Municipality, , Denmark
Copenhagen, , Denmark
Vejle, , Denmark
Lyon, , France
Orléans, , France
Berlin, , Germany
Bochum, , Germany
Hamburg, , Germany
Budapest, , Hungary
Arenzano, , Italy
Siena, , Italy
Valeggio sul Mincio, , Italy
Mexico City, , Mexico
Monterrey, , Mexico
Haugesund, , Norway
Oslo, , Norway
Stavanger, , Norway
Grudziądz, , Poland
Krakow, , Poland
Krakow, , Poland
Cape Town, , South Africa
Pretoria, , South Africa
Sommerset West, , South Africa
Barcelona, , Spain
Madrid, , Spain
Santander, , Spain
Aberdeen, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Bianchi G, Czerwinski E, Kenwright A, Burdeska A, Recker RR, Felsenberg D. Long-term administration of quarterly IV ibandronate is effective and well tolerated in postmenopausal osteoporosis: 5-year data from the DIVA study long-term extension. Osteoporos Int. 2012 Jun;23(6):1769-78. doi: 10.1007/s00198-011-1793-9.
Other Identifiers
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BM16550
Identifier Type: -
Identifier Source: org_study_id
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