Intra-venous Zoledronic Acid Once Yearly

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. Zoledronic acid will be compared to oral bisphosphonates (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.

• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Patient is an ambulatory female 45 years of age or older

• Postmenopausal women with diagnosis of osteoporosis

• Prescription of zoledronic acid or any OBP as per the current Canadian monograph

• Must provide informed consent

Exclusion Criteria:

• Any prior use of iv bisphosphonates within the last 2 years

• Known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease)

• Metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, Paget's disease of bone, Fibrous dysplasia..

• Non-corrected hypocalcaemia at the time of zoledronic acid infusion

• Creatinine clearance < or = 30 ml/min

• Unwillingness or inability to comply with the study requirements

• Concurrent participation in a clinical trial of an investigational drug, or within the last 30 days

Other protocol-defined inclusion/exclusion criteria may apply.