Status:
COMPLETED
Intra-venous Zoledronic Acid Once Yearly
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Post-Menopausal Osteoporosis
Eligibility:
FEMALE
45+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
1551 Patients enrolled
Trial Details
Trial ID
NCT00984893
Start Date
November 1 2008
End Date
April 1 2014
Last Update
March 4 2016
Active Locations (3)
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1
Vancouver, British Columbia, Canada
2
Hamilton, Ontario, Canada
3
Groupe de recherche en rhumatologie et maladies osseuses Inc
Québec, Quebec, Canada