Clinical trial NCT00046254: Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Hip Fracture
Keywords: hip fracture
recurrent fracture
fracture
bone loss
bisphosphonate
bone mineral density
osteoporosis
zoledronic acid
geriatrics
rehabilitation
elderly
nursing home
orthopedic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-09-25
Enrollment: 2127
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Secondary outcomes:
measure: Increase in total hip and femoral neck BMDs
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Eureka
country: United States
facility: Osteoporosis Diagnostic Center
state: California
city: La Mesa
country: United States
facility: Sharp Grossmont Hosptial
state: California
city: Santa Rosa
country: United States
facility: The Permanente Group
state: California
city: Lake Worth
country: United States
facility: Radiant Research Lake Worth
state: Florida
city: Decatur
country: United States
facility: Atlanta Resarch Center
state: Georgia
city: Gainesville
country: United States
facility: United Osteoporosis Center Health Services
state: Georgia
city: Galesburg
country: United States
facility: Galesburg Orthopedic Services LTD
state: Illinois
city: Morton Grove
country: United States
facility: Illinois Bone and Joint Institute
state: Illinois
city: Des Moines
country: United States
facility: Mercy Arthritis and Osteoporosis Center
state: Iowa
city: Portland
country: United States
facility: Maine Medical Center Research Institute
state: Maine
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Detroit
country: United States
facility: Wayne State University, Div. of Endocrinology
state: Michigan
city: Woodbury
country: United States
facility: Health East Osteoporosis Service
state: Minnesota
city: Rochester
country: United States
facility: Highland Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Canfield
country: United States
facility: University Orthopaedics
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System-Presbyterian Medical Center
state: Pennsylvania
city: West Reading
country: United States
facility: Saint Joseph Medical Center
state: Pennsylvania
city: Warwick
country: United States
facility: Saint Josephs
state: Rhode Island
city: Columbia
country: United States
facility: Palmetto Richland Memorial Hospital
state: South Carolina
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Danville
country: United States
facility: Danville Regional Medical Center
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Nuernberg
country: Germany
facility: Novartis
Study officials:
References:
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.
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.
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.
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.
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.