Efficacy and Safety of Zoledronic Acid in the Prevention and Treatment of Corticosteroid Induced Osteoporosis

May 15, 2017 updated by: Novartis Pharmaceuticals
The intake of high doses of corticosteroids is known to play an important role in the weakening of the bones and is thus an increasing fracture risk. Zoledronic acid (Aclasta) is a drug known for its protective effect in some bone diseases (tumors, paget). This study will test the safety and efficacy of zoledronic acid in the prevention and treatment of corticosteroid induced osteoporosis in male and female patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

802

Phase

  • Phase 3

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3708
        • Center for Education and research on Therapeutics (CERTs) of Musculoskeletal Disorders
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • United Osteoporosis Centers
    • Maryland
      • Cumberland, Maryland, United States, 21502
        • Osteoporosis & Clinical Trials
    • Ohio
      • Columbus, Ohio, United States, 43210
        • University of Ohio
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Radiant Research
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Long duration treatment with corticosteroids (started or ongoing)

Exclusion Criteria:

  • History of osteogenesis imperfecta, multiple myeloma or Paget's disease
  • History of Hyperparathyroidism, hyperthyroidism
  • History of Osteomalacia

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent change in lumbar spine Bone Mineral Density at Month 12 relative to baseline.

Secondary Outcome Measures

Outcome Measure
Percent change in lumbar spine Bone Mineral Density at Month 6 relative to baseline
Percent change in total hip, femoral neck, trochanter and distal radius Bone Mineral Density at Months 6 and 12 relative to baseline
Biochemical markers of bone turnover at Baseline, Day 10, Month 3, Month 6, Month 12
Overal safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

January 3, 2005

First Submitted That Met QC Criteria

January 3, 2005

First Posted (Estimate)

January 4, 2005

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

May 15, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446O2306

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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