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

NCT ID: NCT00046254

Last Updated: 2012-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2007-02-28

Brief Summary

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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

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Conditions

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Osteoporosis Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Zoledronic Acid

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Alabama Hospital

Birmingham, Alabama, United States

Site Status

Osteoporosis Diagnostic Center

Eureka, California, United States

Site Status

Sharp Grossmont Hosptial

La Mesa, California, United States

Site Status

The Permanente Group

Santa Rosa, California, United States

Site Status

Radiant Research Lake Worth

Lake Worth, Florida, United States

Site Status

Atlanta Resarch Center

Decatur, Georgia, United States

Site Status

United Osteoporosis Center Health Services

Gainesville, Georgia, United States

Site Status

Galesburg Orthopedic Services LTD

Galesburg, Illinois, United States

Site Status

Illinois Bone and Joint Institute

Morton Grove, Illinois, United States

Site Status

Mercy Arthritis and Osteoporosis Center

Des Moines, Iowa, United States

Site Status

Maine Medical Center Research Institute

Portland, Maine, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Wayne State University, Div. of Endocrinology

Detroit, Michigan, United States

Site Status

Health East Osteoporosis Service

Woodbury, Minnesota, United States

Site Status

Highland Hospital

Rochester, New York, United States

Site Status

University of North Carolina Hospital

Chapel Hill, North Carolina, United States

Site Status

Duke University Health System

Durham, North Carolina, United States

Site Status

University Orthopaedics

Canfield, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

University of Pennsylvania Health System-Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Saint Joseph Medical Center

West Reading, Pennsylvania, United States

Site Status

Saint Josephs

Warwick, Rhode Island, United States

Site Status

Palmetto Richland Memorial Hospital

Columbia, South Carolina, United States

Site Status

Seton Medical Center

Austin, Texas, United States

Site Status

St. Luke's Episcopal Hospital

Houston, Texas, United States

Site Status

Danville Regional Medical Center

Danville, Virginia, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Novartis

Nuremberg, , Germany

Site Status

Countries

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United States Germany

References

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Magaziner JS, Orwig DL, Lyles KW, Nordsletten L, Boonen S, Adachi JD, Recknor C, Colon-Emeric CS, Mesenbrink P, Bucci-Rechtweg C, Su G, Johnson R, Pieper CF. Subgroup variations in bone mineral density response to zoledronic acid after hip fracture. J Bone Miner Res. 2014 Dec;29(12):2545-51. doi: 10.1002/jbmr.2283.

Reference Type DERIVED
PMID: 24839241 (View on PubMed)

Prieto-Alhambra D, Judge A, Arden NK, Cooper C, Lyles KW, Javaid MK. Fracture prevention in patients with cognitive impairment presenting with a hip fracture: secondary analysis of data from the HORIZON Recurrent Fracture Trial. Osteoporos Int. 2014 Jan;25(1):77-83. doi: 10.1007/s00198-013-2420-8. Epub 2013 Jun 28.

Reference Type DERIVED
PMID: 23812596 (View on PubMed)

Adachi JD, Lyles KW, Colon-Emeric CS, Boonen S, Pieper CF, Mautalen C, Hyldstrup L, Recknor C, Nordsletten L, Moore KA, Bucci-Rechtweg C, Su G, Eriksen EF, Magaziner JS. Zoledronic acid results in better health-related quality of life following hip fracture: the HORIZON-Recurrent Fracture Trial. Osteoporos Int. 2011 Sep;22(9):2539-49. doi: 10.1007/s00198-010-1514-9. Epub 2011 Jan 20.

Reference Type DERIVED
PMID: 21249332 (View on PubMed)

Grbic JT, Black DM, Lyles KW, Reid DM, Orwoll E, McClung M, Bucci-Rechtweg C, Su G. The incidence of osteonecrosis of the jaw in patients receiving 5 milligrams of zoledronic acid: data from the health outcomes and reduced incidence with zoledronic acid once yearly clinical trials program. J Am Dent Assoc. 2010 Nov;141(11):1365-70. doi: 10.14219/jada.archive.2010.0082.

Reference Type DERIVED
PMID: 21037195 (View on PubMed)

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. doi: 10.1056/NEJMoa074941. Epub 2007 Sep 17.

Reference Type DERIVED
PMID: 17878149 (View on PubMed)

Other Identifiers

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CZOL446H2310

Identifier Type: -

Identifier Source: org_study_id

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