Conditions: Post Menopausal Osteoporosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1395
Healthy volunteers: no

Brief summary:
This study will assess the efficacy and safety of intravenous administration of Bonviva regimens in women with post-menopausal osteoporosis, compared to oral daily administration. 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.

Detailed description:

Arms:
arm 1: oral placebo daily and IV ibandronate 2 mg q 2 mo arm 2: oral ibandronate 2.5 mg daily and IV placebo q 2 mo and q 3 mo arm 3: oral placebo daily and IV ibandronate 3 mg q 3 mo

Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: ibandronate [Bonviva/Boniva]
Intervention descriptions: intervention 1: 2mg iv every 2 months intervention 2: 2.5mg po daily intervention 3: 3mg iv every 3 months

Protocol document: