A Study of Bonviva (Ibandronate) Once Monthly in Post-Menopausal Women With Osteopenia

Double-blind, Placebo-controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of Oral Ibandronate Once Monthly in Postmenopausal Women With Osteopenia

This 2 arm study will evaluate the efficacy and safety of oral Bonviva 150mg once monthly compared with placebo in post-menopausal women with osteopenia. Patients will be randomized to receive either Bonviva 150mg po monthly, or placebo monthly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• women 45-60 years of age;
• post-menopausal;
• ambulatory.

Exclusion Criteria:

• vertebral fracture (except traumatic fracture such as in a motor vehicle accident);
• low-trauma osteoporotic fracture in any other bone;
• breast cancer diagnosed within last 20 years;
• other malignancy diagnosed within last 10 years, except successfully resected basal cell cancer;
• treatment with any bisphosphonate within last 2 years;
• treatment with other drugs affecting bone metabolism within last 6 months.