• Relative change in mean lumbar spine BMD [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Relative and absolute change in total hip, trochanter, femoral neck BMD [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
• Percentage of responders [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
• Change from baseline in fastin serum CTX [ Time Frame: 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
• AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

• Efficacy: Relative change in mean lumbar spine BMD, 24 mo; absolute change in mean lumbar spine BMD; relative and absolute change in total hip, trochanter, femoral neck BMD, 12, 24 mo, % of BMD responders
• Safety: AEs, lab values

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.

Inclusion Criteria:

• women 55-80 years of age;
• post-menopausal for >=5 years;
• ambulatory.

Exclusion Criteria:

• malignant disease diagnosed within the previous 10 years (except basal cell cancer that has been successfully removed);
• breast cancer within the previous 20 years;
• allergy to bisphosphonates;
• previous treatment with an intravenous bisphosphonate at any time;
• previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within the last year, or >3 months of treatment within the last 2 years.