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.”

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.

Intervention(s) in this Clinical Trial

• Drug: ibandronate [Bonviva/Boniva]
  • 3mg intravenous (iv) injection every 3 months
• Drug: ibandronate [Bonviva/Boniva]
  • 3mg intravenous (iv) infusion every 3 months
• Drug: Alendronate
  • 70mg per oral (po) weekly

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Active Comparator: 3

Primary Measures

• Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes

Secondary Measures

• Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes
• Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes
• Relative Change From Baseline in Actual GFR (Using CG Formula)
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes
• Absolute Change From Baseline in Mean Serum Creatinine.
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes
• Relative Change From Baseline in Mean Serum Creatinine.
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes
• Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes
• Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
  • Time Frame: Baseline and 9 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Hoffmann-La Roche Industry

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00503113

Study ID Number: BA20341

ClinicalTrials.gov Identifier: NCT00503113

Health Authority: United States: Food and Drug Administration