Phase 4
Completed N=719
A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Previously Treated With Bonviva
Post-Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT00081653 ↗
Enrolled (actual)
719
Serious AEs
19.2%
Results posted
Jul 2009
Primary outcomePrimary: Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD — 0.7916; 0.7977; 0.7977; 0.8069 g/cm^2
Summary
This 2 arm study will assess the long-term efficacy and safety of oral treatment with 100mg or 150mg Bonviva in women with post-menopausal osteoporosis who have previously completed Bonviva study BM16549 (MOBILE study). Patients will receive Bonviva either 100mg po monthly, or 150mg po monthly. Patients will also receive daily supplementation with vitamin D and calcium. The anticipated time of study treatment is 2+ years, and the target sample size is 500+ individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD |
0.7916; 0.7977; 0.7977; 0.8069; 0.0061; 0.0097 | — |
| PRIMARY Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD) |
0.8348; 1.2550; 1.6921; 1.7865; 2.1794; 2.4322 | — |
| SECONDARY Absolute Change From Baseline in Mean Total Hip BMD |
0.7680; 0.7862; 0.7669; 0.7888; -0.0004; 0.0025 | — |
| SECONDARY Relative Percent Change From Baseline in Mean Total Hip BMD |
-0.0169; 0.3459; -0.1092; 0.4378; -0.8045; -0.3496 | — |
| SECONDARY Absolute Change From Baseline of Trough Serum CTX |
0.232; 0.219; 0.176; 0.126; -0.055; -0.093 | — |
| SECONDARY Relative Percent Change From Baseline of Trough Serum CTX |
0.232; 0.219; 0.176; 33.109; -24.622; -33.109 | — |
Eligibility Criteria
Inclusion Criteria
- successful completion of Bonviva study BM16549, with at least 75% compliance;
- ambulatory.
Exclusion Criteria
- malignant disease diagnosed within the previous 12 years (except basal cell cancer that has been successfully removed);
- breast cancer diagnosed within the previous 22 years.
Data sourced from ClinicalTrials.gov (NCT00081653). 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.