A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
801 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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