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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


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.


Minimum age: 60 Years. Maximum age: N/A. Gender(s): Female.


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

Page last updated: August 23, 2015

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