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

Osteoporosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046254
• Other study ID #: CZOL446H2310
• Status: Completed
• Phase: Phase 3
• First received: September 24, 2002
• Last updated: May 1, 2012
• Start date: February 2002
• Est. completion date: February 2007

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2127
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Osteoporosis

Intervention

Drug:
• Zoledronic Acid

Locations

Country	Name	City	State
Germany	Novartis	Nuernberg
United States	Seton Medical Center	Austin	Texas
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama Hospital	Birmingham	Alabama
United States	University Orthopaedics	Canfield	Ohio
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Palmetto Richland Memorial Hospital	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	Danville Regional Medical Center	Danville	Virginia
United States	Atlanta Resarch Center	Decatur	Georgia
United States	Mercy Arthritis and Osteoporosis Center	Des Moines	Iowa
United States	Wayne State University, Div. of Endocrinology	Detroit	Michigan
United States	Duke University Health System	Durham	North Carolina
United States	Osteoporosis Diagnostic Center	Eureka	California
United States	United Osteoporosis Center Health Services	Gainesville	Georgia
United States	Galesburg Orthopedic Services LTD	Galesburg	Illinois
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Sharp Grossmont Hosptial	La Mesa	California
United States	Radiant Research Lake Worth	Lake Worth	Florida
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Illinois Bone and Joint Institute	Morton Grove	Illinois
United States	University of Pennsylvania Health System-Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Maine Medical Center Research Institute	Portland	Maine
United States	Highland Hospital	Rochester	New York
United States	The Permanente Group	Santa Rosa	California
United States	Saint Josephs	Warwick	Rhode Island
United States	Saint Joseph Medical Center	West Reading	Pennsylvania
United States	Health East Osteoporosis Service	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Secondary	Increase in total hip and femoral neck BMDs