Conditions: Post-Menopausal Osteoporosis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 781
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day). intervention 2: 2 mg IV every 2 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Protocol document: