Intra-venous Zoledronic Acid Once Yearly

Study Overview
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Brief Summary
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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.

Official Title
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A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates

Conditions
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Post-Menopausal Osteoporosis

Intervention / Treatment
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* Drug: zoledronic acid
* Drug: Any oral bisphosphonates marketed in Canada


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Zoledronic acid<br> | Drug: zoledronic acid<br> <br> |
| Oral Bisphosphonates<br> | Drug: Any oral bisphosphonates marketed in Canada<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA) |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA) |  | 4 years | 
| change in hip BMD as measured by dual energy x-ray absorptiometry (DXA) |  | 4 years | 
| Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA) |  | 4 years | 
| Risk for fractures |  | 4 years | 
| Burden of illness, health care resource utilization, and loss of productivity |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Bone Mineral density, fragility fractures, zoledronic acid., Treatment