Intra-venous Zoledronic Acid Once Yearly (IVORY)

Novartis

Status: Completed

Conditions: Post-Menopausal Osteoporosis

Treatments: Drug: zoledronic acid; Drug: Any oral bisphosphonates marketed in Canada

Study type: Observational

Funder types: Industry

Identifiers

NCT00984893

CZOL446HCA10

Details and patient eligibility

About

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.

Enrollment: 1,551 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,551 participants in 2 patient groups

Zoledronic acid

Treatment:

Drug: zoledronic acid

Oral Bisphosphonates

Treatment:

Drug: Any oral bisphosphonates marketed in Canada