Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00984893
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
45 Years
Study:
NCT00984893
Study Brief:
Protocol Section:
NCT00984893