Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

May 1, 2012 updated by: Novartis Pharmaceuticals
The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

2127

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

  • Germany
      • Nuernberg, Germany
        • Novartis
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Hospital
    • California
      • Eureka, California, United States, 95503
        • Osteoporosis Diagnostic Center
      • La Mesa, California, United States, 91942
        • Sharp Grossmont Hosptial
      • Santa Rosa, California, United States, 95403
        • The Permanente Group
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Radiant Research Lake Worth
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Atlanta Resarch Center
      • Gainesville, Georgia, United States, 30501
        • United Osteoporosis Center Health Services
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Galesburg Orthopedic Services LTD
      • Morton Grove, Illinois, United States, 60053
        • Illinois Bone and Joint Institute
    • Iowa
      • Des Moines, Iowa, United States, 50322
        • Mercy Arthritis and Osteoporosis Center
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Medical Center Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University, Div. of Endocrinology
    • Minnesota
      • Woodbury, Minnesota, United States, 55125
        • Health East Osteoporosis Service
    • New York
      • Rochester, New York, United States, 14620
        • Highland Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Health System
    • Ohio
      • Canfield, Ohio, United States, 44406
        • University Orthopaedics
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System-Presbyterian Medical Center
      • West Reading, Pennsylvania, United States, 19611
        • Saint Joseph Medical Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02818
        • Saint Josephs
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Richland Memorial Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center
      • Houston, Texas, United States, 77030
        • St. Luke's Episcopal Hospital
    • Virginia
      • Danville, Virginia, United States, 24541
        • Danville Regional Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin Hospital and Clinics

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female ages 50 years or older
  • Must have a recent hip fracture repair in the past 90 days
  • Must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture

Exclusion Criteria:

  • Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate)

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
Significant reduction in rate of clinical fractures after surgical repair of hip fracture

Secondary Outcome Measures

Outcome Measure
Increase in total hip and femoral neck BMDs

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

February 1, 2002

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

September 24, 2002

First Submitted That Met QC Criteria

September 24, 2002

First Posted (Estimate)

September 25, 2002

Study Record Updates

Last Update Posted (Estimate)

May 2, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446H2310

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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