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CompletedNCT00046254Updated May 2, 2012

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

A Phase 3 interventional study of Zoledronic Acid in Osteoporosis and Hip Fracture, sponsored by Novartis Pharmaceuticals. Completed at 28 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-05-02.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,127
Allocation
Randomized
Ages
50 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Osteoporosis
  • Hip Fracture

Keywords

  • hip fracture
  • recurrent fracture
  • fracture
  • bone loss
  • bisphosphonate
  • bone mineral density
  • osteoporosis
  • zoledronic acid
  • geriatrics
  • rehabilitation
  • elderly
  • nursing home
  • orthopedic
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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 2,127 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
2,127 participants

Interventions

  • DrugZoledronic Acid
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What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Increase in total hip and femoral neck BMDs

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Study locations

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

Publications

  • 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. PubMed 24839241 ↗
  • 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. PubMed 23812596 ↗
  • 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. PubMed 21249332 ↗
  • 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. PubMed 21037195 ↗
  • 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. PubMed 17878149 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00046254
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 25, 2002
Start date
Feb 2002
Primary completion
Feb 2007
Completion
Feb 2007
Last update
May 2, 2012
View the source record on ClinicalTrials.gov ↗

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