Interventional, Single Arm, Open Label Study of the Efficacy, Safety and Compliance to the Treatment With Intravenous (IV) Ibandronate (Bonviva®) in the Postmenopausal Osteoporosis Treatment of Bisphosphonates naïve Patients in Daily Practice
Overview
- Phase
- Phase 3
- Intervention
- ibandronate [Bonviva/Boniva]
- Conditions
- Post Menopausal Osteoporosis
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 41
- Primary Endpoint
- Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Single Arm
Intervention: ibandronate [Bonviva/Boniva]
Outcomes
Primary Outcomes
Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at Month 12
Time Frame: Baseline, Month 12
Percent change was calculated as \[(measure at time "t" minus \[-\] measure at baseline) divided by (/) measure at baseline\] multiplied by (\*) 100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Lumbar Spine BMD at Month 24
Time Frame: Baseline, Month 24
Percent change was calculated as \[(measure at time "t" - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Hip Bone BMD at Month 12
Time Frame: Baseline, Month 12
Percent change was calculated as \[(measure at time "t" - measure at baseline)/measure at baseline\]\*100, where t=12 months. The baseline value is used as a reference to calculate the relative change from baseline.
Percent Change From Baseline in Mean Hip BMD at Month 24
Time Frame: Baseline, Month 24
Percent change was calculated as \[(measure at time "t" - measure at baseline)/measure at baseline\]\*100, where t=24 months. The baseline value is used as a reference to calculate the relative change from baseline.
Secondary Outcomes
- Correlation Coefficient of Participant's Profile With Compliance(Baseline up to Month 12)
- Percent Change From Baseline in Lumbar Spine T-score at Month 12 and 24(Baseline, Month 12, Month 24)
- Percentage of Participants Who Received All Planned Study Medication (Compliance)(Baseline up to Month 12)
- Percent Change From Baseline in Total Hip T-score at Month 12 and 24(Baseline, Month 12, Month 24)