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.

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.

Study Overview

• Status: Completed
• Conditions: Post-Menopausal Osteoporosis
• Intervention / Treatment: Drug: ibandronate [Bonviva/Boniva]; Drug: ibandronate [Bonviva/Boniva]; Drug: Alendronate

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1425AGC
  • Buenos Aires, Argentina, B1878DVB
  • Buenos Aires, Argentina, C1012-CFed
  • Buenos Aires, Argentina, C1117ABH
  • Buenos Aires, Argentina, C1128AAF
  • Buenos Aires, Argentina, C1405BCH
  • Buenos Aires, Argentina, C1425 AWC
  • Cordoba, Argentina, X5000BNB
  • Santa Fe, Argentina, 2000
• Brazil
  • Brasilia, Brazil, 71625-009
  • Curitiba, Brazil, 80030-110
  • Goiania, Brazil, 74110-120
  • Porto Alegre, Brazil, 90610-000
  • Rio de Janeiro, Brazil, 22271-100
  • Sao Paulo, Brazil, 04266-010
  • Vitoria, Brazil, 29055-450
• Mexico
  • Guadalajara, Mexico, 44629
  • Mexico City, Mexico, 11000
  • Monterrey, Mexico, 64460
  • Obregon, Mexico, 85000
  • San Jerónimo Chicahualco, Mexico, 52170
• South Africa
  • Durban, South Africa, 3630
  • Johannesburg, South Africa, 2196
  • Parow, South Africa, 7500
  • Port Elizabeth, South Africa, 6001
  • Somerset West, South Africa, 7130
• Switzerland
  • Basel, Switzerland, 4055
  • Bern, Switzerland, 3010
  • Zurich, Switzerland, 8091
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
  • California
    • Riverside, California, United States, 92505
  • Colorado
    • Lakewood, Colorado, United States, 80227
  • Florida
    • West Palm Beach, Florida, United States, 33401
  • Georgia
    • Gainesville, Georgia, United States, 30501
  • Kansas
    • Topeka, Kansas, United States, 66604
  • Maryland
    • Bethesda, Maryland, United States, 20817
  • Nebraska
    • Omaha, Nebraska, United States, 68131
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Cincinnati, Ohio, United States, 45224
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
  • Virginia
    • Norfolk, Virginia, United States, 23502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: ibandronate [Bonviva/Boniva]; 3mg intravenous (iv) injection every 3 months; Drug: ibandronate [Bonviva/Boniva]; 3mg intravenous (iv) infusion every 3 months
Experimental: 2	Drug: ibandronate [Bonviva/Boniva]; 3mg intravenous (iv) injection every 3 months; Drug: ibandronate [Bonviva/Boniva]; 3mg intravenous (iv) infusion every 3 months
Active Comparator: 3	Drug: Alendronate; 70mg per oral (po) weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)	Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.	Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)	Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.	Baseline and 9 months
Relative Change From Baseline in Actual GFR (Using CG Formula)	Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.	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
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.		Baseline and 9 months
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.	The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.	Baseline and 9 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: July 17, 2007
• First Submitted That Met QC Criteria: July 17, 2007
• First Posted (Estimate): July 18, 2007

Study Record Updates

• Last Update Posted (Estimate): June 17, 2011
• Last Update Submitted That Met QC Criteria: May 17, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Bone Density Conservation Agents; Alendronate; Ibandronic Acid
• Other Study ID Numbers: BA20341