Clinical trial NCT00503113: A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Menopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 801
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
timeFrame: Baseline and 9 months
Secondary outcomes:
measure: Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
timeFrame: Baseline and 9 months
measure: Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
timeFrame: Baseline and 9 months
measure: Relative Change From Baseline in Actual GFR (Using CG Formula)
timeFrame: Baseline and 9 months
measure: Absolute Change From Baseline in Mean Serum Creatinine.
timeFrame: Baseline and 9 months
measure: Relative Change From Baseline in Mean Serum Creatinine.
timeFrame: Baseline and 9 months
measure: Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
timeFrame: Baseline and 9 months
measure: Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
timeFrame: Baseline and 9 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Riverside
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: West Palm Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Georgia
city: Topeka
country: United States
state: Kansas
city: Bethesda
country: United States
state: Maryland
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Morehead City
country: United States
state: North Carolina
city: Bismarck
country: United States
state: North Dakota
city: Fargo
country: United States
state: North Dakota
city: Cincinnati
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Norfolk
country: United States
state: Virginia
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Santa Fe
country: Argentina
city: Brasilia
country: Brazil
city: Curitiba
country: Brazil
city: Goiania
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Vitoria
country: Brazil
city: Guadalajara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Obregon
country: Mexico
city: San Jerónimo Chicahualco
country: Mexico
city: Durban
country: South Africa
city: Johannesburg
country: South Africa
city: Parow
country: South Africa
city: Port Elizabeth
country: South Africa
city: Somerset West
country: South Africa
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Zurich
country: Switzerland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.