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 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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Change from baseline in actual GFR
  • Time Frame: 9 months
    Safety Issue?: Yes

Secondary Measures

• Relative and absolute change in mean actual GFR, serum creatinine and urine albumin-creatinine ratio
  • Time Frame: 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 Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Overall Contact: Please reference Study ID Number: PDO_BA20341 973-235-5000 

Information obtained from ClinicalTrials.gov on November 20, 2008

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