A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

A One Year, Local, Open Label, Multicentre Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on BMD and Biochemical Markers of Bone in PMO Pts Between the Ages of 50 and 65 Years

This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.

Inclusion Criteria:

• Postmenopausal osteoporosis
• Patients who has a low bone mineral density at hip or vertebral
• Patients who has an osteoporotic fracture at hip or vertebra

Exclusion Criteria:

• Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
• Known metabolic bone disease excluding osteoporosis.
• Serious systemic disorder treated with drugs interfering with bone metabolism.
• Significant liver or renal failure
• Pathologic fracture in the examined body area or elsewhere.
• Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
• Patients with hypocalcaemia

Other protocol-defined inclusion/exclusion criteria may apply