Phase 4
Completed N=781
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment
Post-Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT00551174 ↗
Enrolled (actual)
781
Serious AEs
22.3%
Results posted
May 2011
Primary outcomePrimary: Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months — 0.7969; 0.7861; 0.8378; 0.8845 Percent change
Summary
This 2-arm study was designed to assess the long-term safety and tolerability of intravenous (IV) treatment with 2 mg or 3 mg Bonviva in women with post-menopausal osteoporosis who had previously completed Bonviva study BM16550 (DIVA study; NCT00048074). Patients received Bonviva either 2 mg IV every 2 months, or 3 mg IV every 3 months. Patients also received daily supplementation with vitamin D and calcium. The anticipated time on study treatment was 2+ years, and the target sample size was 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months |
0.7969; 0.7861; 0.8378; 0.8845; 1.6785; 1.5742 | — |
| SECONDARY Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months |
0.7651; 0.7665; 0.4487; 0.1258; 0.0483; -0.049 | — |
| SECONDARY Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months |
0.232; 0.264; 17.562; 20.091; 35.934; 34.009 | — |
| SECONDARY Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months |
0.232; 0.264; -78.024; -81.617 | — |
Eligibility Criteria
Inclusion Criteria
- Successful completion of Bonviva study BM16550 (NCT00048074), with at least 75% compliance
- Ambulatory
Exclusion Criteria
- Patients who completed the Bonviva study BM16550 (NCT00048074) >3 months before the planned start date for this study
- Malignant disease diagnosed since inclusion into previous study
- Treatment with drugs affecting bone metabolism since inclusion into previous study
Data sourced from ClinicalTrials.gov (NCT00551174). 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.