Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
1 other identifier
interventional
2,127
2 countries
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2002
Longer than P75 for phase_3
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 24, 2002
CompletedFirst Posted
Study publicly available on registry
September 25, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMay 2, 2012
May 1, 2012
5 years
September 24, 2002
May 1, 2012
Conditions
Keywords
Outcome Measures
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
Nuremberg, Germany
Related Publications (5)
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.
PMID: 24839241DERIVEDPrieto-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.
PMID: 23812596DERIVEDAdachi 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.
PMID: 21249332DERIVEDGrbic 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.
PMID: 21037195DERIVEDLyles 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.
PMID: 17878149DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2002
First Posted
September 25, 2002
Study Start
February 1, 2002
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
May 2, 2012
Record last verified: 2012-05