A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post-Menopausal Osteoporosis
Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug); Alendronate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: 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.
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
Secondary outcome: Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) Relative Change From Baseline in Actual GFR (Using CG Formula) Absolute Change From Baseline in Mean Serum Creatinine. Relative Change From Baseline in Mean Serum Creatinine. Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- female patients, >=60 years of age;
- >=5 years postmenopausal;
- confirmed osteoporosis, at increased risk for renal disease.
Exclusion Criteria:
- 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.
Locations and Contacts
Buenos Aires C1425 AWC, Argentina
Buenos Aires C1012-CFed, Argentina
Buenos Aires C1117ABH, Argentina
Buenos Aires C1128AAF, Argentina
Buenos Aires C1405BCH, Argentina
Buenos Aires B1878DVB, Argentina
Buenos Aires C1425AGC, Argentina
Cordoba X5000BNB, Argentina
Santa Fe 2000, Argentina
Brasilia 71625-009, Brazil
Curitiba 80030-110, Brazil
Goiania 74110-120, Brazil
Porto Alegre 90610-000, Brazil
Rio de Janeiro 22271-100, Brazil
Sao Paulo 04266-010, Brazil
Vitoria 29055-450, Brazil
Guadalajara 44629, Mexico
Mexico City 11000, Mexico
Monterrey 64460, Mexico
Obregon 85000, Mexico
San Jerónimo Chicahualco 52170, Mexico
Durban 3630, South Africa
Johannesburg 2196, South Africa
Parow 7500, South Africa
Port Elizabeth 6001, South Africa
Somerset West 7130, South Africa
Basel 4055, Switzerland
Bern 3010, Switzerland
Zurich 8091, Switzerland
Birmingham, Alabama 35294, United States
Riverside, California 92505, United States
Lakewood, Colorado 80227, United States
West Palm Beach, Florida 33401, United States
Gainesville, Georgia 30501, United States
Topeka, Kansas 66604, United States
Bethesda, Maryland 20817, United States
Omaha, Nebraska 68131, United States
Albuquerque, New Mexico 87106, United States
Morehead City, North Carolina 28557, United States
Bismarck, North Dakota 58501, United States
Fargo, North Dakota 58103, United States
Cincinnati, Ohio 45224, United States
Duncansville, Pennsylvania 16635, United States
Norfolk, Virginia 23502, United States
Additional Information
Starting date: July 2007
Last updated: May 17, 2011
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