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

Primary Purpose

Osteoporosis, Hip Fracture

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring hip fracture, recurrent fracture, fracture, bone loss, bisphosphonate, bone mineral density, osteoporosis, zoledronic acid, geriatrics, rehabilitation, elderly, nursing home, orthopedic

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama Hospital
  • Osteoporosis Diagnostic Center
  • Sharp Grossmont Hosptial
  • The Permanente Group
  • Radiant Research Lake Worth
  • Atlanta Resarch Center
  • United Osteoporosis Center Health Services
  • Galesburg Orthopedic Services LTD
  • Illinois Bone and Joint Institute
  • Mercy Arthritis and Osteoporosis Center
  • Maine Medical Center Research Institute
  • University of Maryland School of Medicine
  • Wayne State University, Div. of Endocrinology
  • Health East Osteoporosis Service
  • Highland Hospital
  • University of North Carolina Hospital
  • Duke University Health System
  • University Orthopaedics
  • Ohio State University
  • University of Pennsylvania Health System-Presbyterian Medical Center
  • Saint Joseph Medical Center
  • Saint Josephs
  • Palmetto Richland Memorial Hospital
  • Seton Medical Center
  • St. Luke's Episcopal Hospital
  • Danville Regional Medical Center
  • University of Wisconsin Hospital and Clinics
  • Novartis

Outcomes

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

Full Information

First Posted
September 24, 2002
Last Updated
May 1, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00046254
Brief Title
Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Hip Fracture
Keywords
hip fracture, recurrent fracture, fracture, bone loss, bisphosphonate, bone mineral density, osteoporosis, zoledronic acid, geriatrics, rehabilitation, elderly, nursing home, orthopedic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
2127 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Secondary Outcome Measure Information:
Title
Increase in total hip and femoral neck BMDs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Osteoporosis Diagnostic Center
City
Eureka
State/Province
California
ZIP/Postal Code
95503
Country
United States
Facility Name
Sharp Grossmont Hosptial
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
The Permanente Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Radiant Research Lake Worth
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Atlanta Resarch Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
United Osteoporosis Center Health Services
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Galesburg Orthopedic Services LTD
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois Bone and Joint Institute
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Mercy Arthritis and Osteoporosis Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50322
Country
United States
Facility Name
Maine Medical Center Research Institute
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Wayne State University, Div. of Endocrinology
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Health East Osteoporosis Service
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Highland Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
University of North Carolina Hospital
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Health System
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Orthopaedics
City
Canfield
State/Province
Ohio
ZIP/Postal Code
44406
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Health System-Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Saint Joseph Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Saint Josephs
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Palmetto Richland Memorial Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Seton Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
Facility Name
Novartis
City
Nuernberg
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24839241
Citation
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.
Results Reference
derived
PubMed Identifier
23812596
Citation
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.
Results Reference
derived
PubMed Identifier
21249332
Citation
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.
Results Reference
derived
PubMed Identifier
21037195
Citation
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.
Results Reference
derived
PubMed Identifier
17878149
Citation
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.
Results Reference
derived

Learn more about this trial

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

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