Intra-venous Zoledronic Acid Once Yearly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1551 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-04-30

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.

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Detailed Description

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Conditions

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Post-Menopausal Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Zoledronic acid

zoledronic acid

Intervention Type DRUG

Oral Bisphosphonates

Any oral bisphosphonates marketed in Canada

Intervention Type DRUG

Interventions

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zoledronic acid

Intervention Type DRUG

Any oral bisphosphonates marketed in Canada

Intervention Type DRUG

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

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No