Intra-venous Zoledronic Acid Once Yearly

Post-Menopausal Osteoporosis Clinical Trial

— IVORY  

Official title:

A Real-world Study Cohort of Postmenopausal Women With Osteoporosis Taking Zoledronic Acid or Oral Bisphosphonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00984893
• Other study ID #: CZOL446HCA10
• Status: Completed
• Phase: N/A
• First received: September 23, 2009
• Last updated: March 3, 2016
• Start date: November 2008
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1551
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Post-Menopausal Osteoporosis

Intervention

Drug:
• zoledronic acid

• Any oral bisphosphonates marketed in Canada

Locations

Country	Name	City	State
Canada	Groupe de recherche en rhumatologie et maladies osseuses Inc	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)		4 years	No
Secondary	change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)		4 years	No
Secondary	change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)		4 years	No
Secondary	Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)		4 years	No
Secondary	Risk for fractures		4 years	No
Secondary	Burden of illness, health care resource utilization, and loss of productivity		4 years	No