Intra-venous Zoledronic Acid Once Yearly

Completed

• Conditions: Post-Menopausal Osteoporosis
• Interventions: Drug: Any oral bisphosphonates marketed in Canada; Drug: zoledronic acid

• Registration Number: NCT00984893
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-09-23
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1551

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Bisphosphonates	Any oral bisphosphonates marketed in Canada	-
Zoledronic acid	zoledronic acid	-

Primary Outcome Measures

Name	Time	Method
Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)	4 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Groupe de recherche en rhumatologie et maladies osseuses Inc; 🇨🇦 Quebec, Canada