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

Phase 3

Completed

• Conditions: Osteoporosis; Hip Fracture

• Registration Number: NCT00046254
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-09-24
• Study First Submitted QC: 2002-09-24
• Study First Posted: 2002-09-25
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-01
• Last Update Posted: 2012-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2127

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Significant reduction in rate of clinical fractures after surgical repair of hip fracture

Secondary Outcome Measures

Name	Time	Method
Increase in total hip and femoral neck BMDs

Trial Locations

Locations (28)

University of Alabama Hospital; 🇺🇸 Birmingham, Alabama, United States

Osteoporosis Diagnostic Center; 🇺🇸 Eureka, California, United States

Sharp Grossmont Hosptial; 🇺🇸 La Mesa, California, United States

The Permanente Group; 🇺🇸 Santa Rosa, California, United States

Radiant Research Lake Worth; 🇺🇸 Lake Worth, Florida, United States

Atlanta Resarch Center; 🇺🇸 Decatur, Georgia, United States

United Osteoporosis Center Health Services; 🇺🇸 Gainesville, Georgia, United States

Galesburg Orthopedic Services LTD; 🇺🇸 Galesburg, Illinois, United States

Illinois Bone and Joint Institute; 🇺🇸 Morton Grove, Illinois, United States

Mercy Arthritis and Osteoporosis Center; 🇺🇸 Des Moines, Iowa, United States

Scroll for more (18 remaining)