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

• Status: Completed
• Trial end date: 2011-12-16
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

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