Post-Menopausal Osteoporosis
Conditions
Keywords
Osteoporosis, Bone Mineral density, fragility fractures, zoledronic acid., Treatment
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 (OBP) with respect to the change in Bone Mineral Density (BMD) and incidence of fractures.
Interventions
DRUGzoledronic acid
DRUGAny oral bisphosphonates marketed in Canada
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA) | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| change in femoral neck 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 |
Countries
Canada
Outcome results
None listed