A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

Condition(s) targeted: Post-Menopausal Osteoporosis

Intervention: ibandronate [Bonviva/Boniva] (Drug); ibandronate [Bonviva/Boniva] (Drug); Alendronate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

Overall contact:
Please reference Study ID Number: PDO_BA20341, Phone: 973-235-5000

This 3 arm study will evaluate renal safety after administration of an intravenous 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 i. v. by a) injection or b)infusion once every 3 months, or alendronate 70mg p. o. weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study

Primary outcome: Change from baseline in actual GFR

Secondary outcome: Relative and absolute change in mean actual GFR, serum creatinine and urine albumin-creatinine ratio

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.

Please reference Study ID Number: PDO_BA20341, Phone: 973-235-5000

BUENOS AIRES C1128AAF, Argentina; Recruiting

BUENOS AIRES C1012-CFed, Argentina; Recruiting

BUENOS AIRES C1117ABH, Argentina; Recruiting

BUENOS AIRES B1878DVB, Argentina; Recruiting

BUENOS AIRES C1425 AWC, Argentina; Recruiting

BUENOS AIRES C 1425 AWC, Argentina; Recruiting

SANTA FE 2000, Argentina; Recruiting

CORDOBA X5000BNB, Argentina; Recruiting

BUENOS AIRES C1405BCH, Argentina; Recruiting

BRASILIA 71625-009, Brazil; Recruiting

SAO PAULO 04230-000, Brazil; Recruiting

VITORIA 29055-450, Brazil; Recruiting

RIO DE JANEIRO 22271-100, Brazil; Recruiting

CURITIBA 80030-110, Brazil; Recruiting

GOIANIA 74043-011, Brazil; Recruiting

PORTO ALEGRE 90610-000, Brazil; Recruiting

MONTERREY 64460, Mexico; Recruiting

MEXICO CITY 11000, Mexico; Recruiting

GUADALAJARA 44620, Mexico; Recruiting

SAN JERÓNIMO CHICAHUALCO 52170, Mexico; Recruiting

OBREGON 85000, Mexico; Recruiting

PORT ELIZABETH 6001, South Africa; Recruiting

DURBAN 3630, South Africa; Recruiting

SOMMERSET WEST 7129, South Africa; Recruiting

JOHANNESBURG 2196, South Africa; Recruiting

PAROW 7500, South Africa; Recruiting

ZÜRICH 8091, Switzerland; Recruiting

BASEL 4055, Switzerland; Recruiting

BERN 3010, Switzerland; Recruiting

BIRMINGHAM, Alabama 35294, United States; Recruiting

RIVERSIDE, California 92505, United States; Recruiting

LAKEWOOD, Colorado 80227, United States; Recruiting

WEST PALM BEACH, Florida 33401, United States; Recruiting

GAINESVILLE, Georgia 30501, United States; Recruiting

TOPEKA, Kansas 66604, United States; Recruiting

BETHESDA, Maryland 20817, United States; Recruiting

OMAHA, Nebraska 68131, United States; Recruiting

ALBUQUERQUE, New Mexico 87106, United States; Recruiting

MOREHEAD CITY, North Carolina 28557, United States; Recruiting

FARGO, North Dakota 58103, United States; Recruiting

BISMARCK, North Dakota 58501, United States; Recruiting

CINCINNATI, Ohio 45224, United States; Recruiting

DUNCANSVILLE, Pennsylvania 16635, United States; Recruiting

NORFOLK, Virginia 23502, United States; Recruiting

Starting date: July 2007
Ending date: May 2010
Last updated: October 15, 2008