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

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00046254

Purpose

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.

Condition	Intervention	Phase
Osteoporosis Hip Fracture	Drug: Zoledronic Acid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Osteoporosis

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Increase in total hip and femoral neck BMDs

Estimated Enrollment:	2127
Study Start Date:	February 2002

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046254

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Locations

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

Sponsors and Collaborators

Novartis

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Lyles KW, Colon-Emeric CS, Magaziner JS, Adachi JD, Pieper CF, Mautalen C, Hyldstrup L, Recknor C, Nordsletten L, Moore KA, Lavecchia C, Zhang J, Mesenbrink P, Hodgson PK, Abrams K, Orloff JJ, Horowitz Z, Eriksen EF, Boonen S; HORIZON Recurrent Fracture Trial. Zoledronic acid and clinical fractures and mortality after hip fracture. N Engl J Med. 2007 Nov 1;357(18):1799-809. Epub 2007 Sep 17.

Study ID Numbers:	CZOL446H2310
Study First Received:	September 24, 2002
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00046254 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

hip fracture
recurrent fracture
fracture
bone loss
bisphosphonate
bone mineral density
osteoporosis

zoledronic acid
geriatrics
rehabilitation
elderly
nursing home
orthopedic

Additional relevant MeSH terms:

Zoledronic acid
Physiological Effects of Drugs
Fractures, Bone
Wounds and Injuries
Osteoporosis
Disorders of Environmental Origin
Bone Density Conservation Agents
Bone Diseases, Metabolic

Hip Injuries
Bone Diseases
Pharmacologic Actions
Hip Fractures
Femoral Fractures
Diphosphonates
Musculoskeletal Diseases
Leg Injuries

ClinicalTrials.gov processed this record on November 27, 2009