Phase 3
Completed N=41
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
Post Menopausal Osteoporosis
Source: ClinicalTrials.gov NCT01290094 ↗
Enrolled (actual)
41
Serious AEs
22.5%
Results posted
Aug 2015
Primary outcomePrimary: Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 — 5.67 percent change — p=<0.0005
Summary
This single arm, open label study will assess the efficacy and safety of and compliance to treatment with Bonviva/Boniva (ibandronate) in biphosphonate-naïve patients with post-menopausal osteoporosis. Patients will receive Bonviva/Boniva at a dose of 3 mg intravenously every three months. Anticipated time on study treatment is 12 months with a follow-up of 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12 |
5.67 | <0.0005 sig |
| PRIMARY Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24 |
5.27 | <0.0005 sig |
| PRIMARY Percent Change From Baseline in Mean Hip Bone BMD at Month 12 |
2.68 | 0.001 sig |
| PRIMARY Percent Change From Baseline in Mean Hip BMD at Month 24 |
1.71 | 0.056 |
| SECONDARY Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24 |
13.47; 12.48 | <0.0005 sig |
| SECONDARY Percent Change From Baseline in Total Hip T-score at Month 12 and 24 |
9.31; 5.98 | <0.0005 sig |
| SECONDARY Percentage of Participants Who Received All Planned Study Medication (Compliance) |
100 | — |
| SECONDARY Correlation Coefficient of Participant's Profile With Compliance |
NA | — |
Eligibility Criteria
Inclusion Criteria
- Female patients, > 50 years of age
- Diagnosed osteoporosis
- Bone mineral density < minus 2.5 SD or osteoporotic fracture
- At least 3 years after menopause
Exclusion Criteria
- Impaired renal function
- Contra-indication to Calcium or Vitamin D therapy
- Previous or current treatment with biphosphonates
Data sourced from ClinicalTrials.gov (NCT01290094). 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.