Intra-venous Zoledronic Acid Once Yearly (IVORY)

March 3, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1551

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Groupe de recherche en rhumatologie et maladies osseuses Inc
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Ambulatory Female patients, at least 45 years of age, diagnosed with osteoporosis and taking either Zelodronic acid or any other oral bisphosphonates (OBP) as per the current Canadian monograph

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Zoledronic acid
Drug: zoledronic acid
Oral Bisphosphonates
Drug: Any oral bisphosphonates marketed in Canada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change in lumbar spine BMD as measured by dual energy x-ray absorptiometry (DXA)
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
change in femoral neck BMD as measured by dual energy x-ray absorptiometry (DXA)
Time Frame: 4 years
4 years
change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
Time Frame: 4 years
4 years
Percent change in hip BMD as measured by dual energy x-ray absorptiometry (DXA)
Time Frame: 4 years
4 years
Risk for fractures
Time Frame: 4 years
4 years
Burden of illness, health care resource utilization, and loss of productivity
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Marc Vaillancourt, Novartis Pharmaceuticals Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 23, 2009

First Submitted That Met QC Criteria

September 24, 2009

First Posted (Estimate)

September 25, 2009

Study Record Updates

Last Update Posted (Estimate)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 3, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446HCA10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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