A Study of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Who Have Received Previous Bonviva Treatment

Roche

Status and phase: Completed; Phase 4

Conditions: Post-Menopausal Osteoporosis

Treatments: Drug: ibandronate [Bonviva/Boniva]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551174

MA17904

Details and patient eligibility

About

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.

Enrollment: 781 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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781 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]

2

Active Comparator group

Treatment:

Drug: ibandronate [Bonviva/Boniva]

Drug: ibandronate [Bonviva/Boniva]