MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis
NCT ID: NCT00048061
Last Updated: 2018-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1609 participants
INTERVENTIONAL
2002-04-30
2004-12-31
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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Ibandronate 2.5 mg
Participants will receive 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly. Participants will also receive calcium 500 mg /day and vitamin D 400 international units (IU)/day .
Ibandronate [Bonviva/Boniva]
2.5mg po daily
Calcium
500 mg/day
Vitamin D
400 IU/day
Ibandronate 50/50 mg
Participants will receive 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day.
Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Calcium
500 mg/day
Vitamin D
400 IU/day
Ibandronate 100 mg
Participants will receive 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Calcium
500 mg/day
Vitamin D
400 IU/day
Ibandronate 150 mg
Participants will receive 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants will also receive calcium 500 mg /day and vitamin D 400 IU/day
Ibandronate [Bonviva/Boniva]
150mg po monthly
Calcium
500 mg/day
Vitamin D
400 IU/day
Interventions
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Ibandronate [Bonviva/Boniva]
2.5mg po daily
Ibandronate [Bonviva/Boniva]
100mg po monthly on a single day
Ibandronate [Bonviva/Boniva]
100mg po monthly over 2 consecutive days
Ibandronate [Bonviva/Boniva]
150mg po monthly
Calcium
500 mg/day
Vitamin D
400 IU/day
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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Irvine, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Oakland, California, United States
Rancho Mirage, California, United States
Lakewood, Colorado, United States
Gainesville, Florida, United States
Bethesda, Maryland, United States
Wheaton, Maryland, United States
St Louis, Missouri, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Livingston, New Jersey, United States
Albuquerque, New Mexico, United States
Portland, Oregon, United States
Wyomissing, Pennsylvania, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Adelaide, , Australia
Adelaide, , Australia
Parkville, , Australia
Perth, , Australia
Liège, , Belgium
Merksem, , Belgium
Campinas, , Brazil
Curitiba, , Brazil
Porto Alegre, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Vejle, , Denmark
Caen, , France
Lyon, , France
Berlin, , Germany
Hanover, , Germany
Balatonfüred, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Kiskunhalas, , Hungary
Zalaegerszeg, , Hungary
Siena, , Italy
Valeggio sul Mincio, , Italy
León, , Mexico
Obregón, , Mexico
Haugesund, , Norway
Oslo, , Norway
Stavanger, , Norway
Krakow, , Poland
Warsaw, , Poland
Bucharest, , Romania
Cape Town, , South Africa
Johannesburg, , South Africa
Barcelona, , Spain
Madrid, , Spain
Zurich, , Switzerland
Cardiff, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Southampton, , United Kingdom
Countries
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Other Identifiers
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BM16549
Identifier Type: -
Identifier Source: org_study_id
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