A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
NCT ID: NCT00503113
Last Updated: 2011-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
801 participants
INTERVENTIONAL
2007-07-31
2010-04-30
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
NONE
Study Groups
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1
ibandronate [Bonviva/Boniva]
3mg intravenous (iv) injection every 3 months
2
ibandronate [Bonviva/Boniva]
3mg intravenous (iv) infusion every 3 months
3
Alendronate
70mg per oral (po) weekly
Interventions
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ibandronate [Bonviva/Boniva]
3mg intravenous (iv) injection every 3 months
ibandronate [Bonviva/Boniva]
3mg intravenous (iv) infusion every 3 months
Alendronate
70mg per oral (po) weekly
Eligibility Criteria
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Inclusion Criteria
* \>=5 years postmenopausal;
* confirmed osteoporosis, at increased risk for renal disease.
Exclusion Criteria
* hypersensitivity to bisphosphonates;
* malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
* previous administration of an i.v. bisphosphonate;
* oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
* history of major upper gastrointestinal disease.
60 Years
FEMALE
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Riverside, California, United States
Lakewood, Colorado, United States
West Palm Beach, Florida, United States
Gainesville, Georgia, United States
Topeka, Kansas, United States
Bethesda, Maryland, United States
Omaha, Nebraska, United States
Albuquerque, New Mexico, United States
Morehead City, North Carolina, United States
Bismarck, North Dakota, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Duncansville, Pennsylvania, United States
Norfolk, Virginia, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Brasília, , Brazil
Curitiba, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Vitória, , Brazil
Guadalajara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
Obregón, , Mexico
San Jerónimo, , Mexico
Durban, , South Africa
Johannesburg, , South Africa
Parow, , South Africa
Port Elizabeth, , South Africa
Somerset West, , South Africa
Basel, , Switzerland
Bern, , Switzerland
Zurich, , Switzerland
Countries
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References
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Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
Other Identifiers
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BA20341
Identifier Type: -
Identifier Source: org_study_id
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