Phase 4
Completed N=801
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Post-Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT00503113 ↗
Enrolled (actual)
801
Serious AEs
5.9%
Results posted
Jun 2011
Primary outcomePrimary: Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) — 72.5; 71.5; 70.5; -1.3 mL/min
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula) |
72.5; 71.5; 70.5; -1.3; -0.5; -1.6 | — |
| SECONDARY Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) |
65.0; 62.9; 62.0; -1.6; -1.0; -1.9 | — |
| SECONDARY Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) |
72.5; 71.5; 70.5; -1.4; -0.2; -2.1 | — |
| SECONDARY Relative Change From Baseline in Actual GFR (Using CG Formula) |
65.0; 62.9; 62.0; -2.3; -1.3; -2.8 | — |
| SECONDARY Absolute Change From Baseline in Mean Serum Creatinine. |
0.8; 0.8; 0.8; 0.0; 0.0; 0.0 | — |
| SECONDARY Relative Change From Baseline in Mean Serum Creatinine. |
0.8; 0.8; 0.8; 1.7; 0.8; 2.2 | — |
| SECONDARY Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. |
16.0; 14.1; 16.1; -0.8; 0.5; 1.4 | — |
| SECONDARY Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. |
16.0; 14.1; 16.1; 21.6; 15.6; 28.3 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00503113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.