MedPath

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

Phase 3
Completed
Conditions
Osteoporosis
Hip Fracture
Registration Number
NCT00046254
Lead Sponsor
Novartis Pharmaceuticals
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
2127
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Secondary Outcome Measures
NameTimeMethod
Increase in total hip and femoral neck BMDs

Trial Locations

Locations (28)

Novartis

馃嚛馃嚜

Nuernberg, Germany

Radiant Research Lake Worth

馃嚭馃嚫

Lake Worth, Florida, United States

University of Wisconsin Hospital and Clinics

馃嚭馃嚫

Madison, Wisconsin, United States

University of Alabama Hospital

馃嚭馃嚫

Birmingham, Alabama, United States

Galesburg Orthopedic Services LTD

馃嚭馃嚫

Galesburg, Illinois, United States

Maine Medical Center Research Institute

馃嚭馃嚫

Portland, Maine, United States

University of Maryland School of Medicine

馃嚭馃嚫

Baltimore, Maryland, United States

Wayne State University, Div. of Endocrinology

馃嚭馃嚫

Detroit, Michigan, United States

University of Pennsylvania Health System-Presbyterian Medical Center

馃嚭馃嚫

Philadelphia, Pennsylvania, United States

Health East Osteoporosis Service

馃嚭馃嚫

Woodbury, Minnesota, United States

Duke University Health System

馃嚭馃嚫

Durham, North Carolina, United States

Ohio State University

馃嚭馃嚫

Columbus, Ohio, United States

Palmetto Richland Memorial Hospital

馃嚭馃嚫

Columbia, South Carolina, United States

St. Luke's Episcopal Hospital

馃嚭馃嚫

Houston, Texas, United States

Sharp Grossmont Hosptial

馃嚭馃嚫

La Mesa, California, United States

Illinois Bone and Joint Institute

馃嚭馃嚫

Morton Grove, Illinois, United States

Mercy Arthritis and Osteoporosis Center

馃嚭馃嚫

Des Moines, Iowa, United States

The Permanente Group

馃嚭馃嚫

Santa Rosa, California, United States

Atlanta Resarch Center

馃嚭馃嚫

Decatur, Georgia, United States

United Osteoporosis Center Health Services

馃嚭馃嚫

Gainesville, Georgia, United States

Osteoporosis Diagnostic Center

馃嚭馃嚫

Eureka, California, United States

University Orthopaedics

馃嚭馃嚫

Canfield, Ohio, United States

Highland Hospital

馃嚭馃嚫

Rochester, New York, United States

University of North Carolina Hospital

馃嚭馃嚫

Chapel Hill, North Carolina, United States

Saint Joseph Medical Center

馃嚭馃嚫

West Reading, Pennsylvania, United States

Saint Josephs

馃嚭馃嚫

Warwick, Rhode Island, United States

Seton Medical Center

馃嚭馃嚫

Austin, Texas, United States

Danville Regional Medical Center

馃嚭馃嚫

Danville, Virginia, United States

漏 Copyright 2025. All Rights Reserved by MedPath