A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
1 other identifier
interventional
801
6 countries
44
Brief Summary
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2007
Typical duration for phase_4
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
June 17, 2011
CompletedJune 17, 2011
May 1, 2011
2.8 years
July 17, 2007
March 31, 2011
May 17, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Baseline and 9 months
Secondary Outcomes (7)
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using CG Formula)
Baseline and 9 months
Absolute Change From Baseline in Mean Serum Creatinine.
Baseline and 9 months
Relative Change From Baseline in Mean Serum Creatinine.
Baseline and 9 months
- +2 more secondary outcomes
Study Arms (3)
1
EXPERIMENTAL2
EXPERIMENTAL3
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- female patients, \>=60 years of age;
- \>=5 years postmenopausal;
- confirmed osteoporosis, at increased risk for renal disease.
You may not qualify if:
- inability to stand or sit upright for 30 minutes;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Riverside, California, 92505, United States
Unknown Facility
Lakewood, Colorado, 80227, United States
Unknown Facility
West Palm Beach, Florida, 33401, United States
Unknown Facility
Gainesville, Georgia, 30501, United States
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Topeka, Kansas, 66604, United States
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Bethesda, Maryland, 20817, United States
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Omaha, Nebraska, 68131, United States
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Albuquerque, New Mexico, 87106, United States
Unknown Facility
Morehead City, North Carolina, 28557, United States
Unknown Facility
Bismarck, North Dakota, 58501, United States
Unknown Facility
Fargo, North Dakota, 58103, United States
Unknown Facility
Cincinnati, Ohio, 45224, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Norfolk, Virginia, 23502, United States
Unknown Facility
Buenos Aires, B1878DVB, Argentina
Unknown Facility
Buenos Aires, C1012-CFed, Argentina
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Buenos Aires, C1117ABH, Argentina
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Buenos Aires, C1128AAF, Argentina
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Buenos Aires, C1405BCH, Argentina
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Buenos Aires, C1425 AWC, Argentina
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Buenos Aires, C1425AGC, Argentina
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Córdoba, X5000BNB, Argentina
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Santa Fe, 2000, Argentina
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Brasília, 71625-009, Brazil
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Curitiba, 80030-110, Brazil
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Goiânia, 74110-120, Brazil
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Porto Alegre, 90610-000, Brazil
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Rio de Janeiro, 22271-100, Brazil
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São Paulo, 04266-010, Brazil
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Vitória, 29055-450, Brazil
Unknown Facility
Guadalajara, 44629, Mexico
Unknown Facility
Mexico City, 11000, Mexico
Unknown Facility
Monterrey, 64460, Mexico
Unknown Facility
Obregón, 85000, Mexico
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San Jerónimo, 52170, Mexico
Unknown Facility
Durban, 3630, South Africa
Unknown Facility
Johannesburg, 2196, South Africa
Unknown Facility
Parow, 7500, South Africa
Unknown Facility
Port Elizabeth, 6001, South Africa
Unknown Facility
Somerset West, 7130, South Africa
Unknown Facility
Basel, 4055, Switzerland
Unknown Facility
Bern, 3010, Switzerland
Unknown Facility
Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 34231877DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 17, 2007
First Posted
July 18, 2007
Study Start
July 1, 2007
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
June 17, 2011
Results First Posted
June 17, 2011
Record last verified: 2011-05