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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00046254

Collaborator

(none)

2,127

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis Hip Fracture	Drug: Zoledronic Acid	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Feb 1, 2002

Actual Primary Completion Date :

Feb 1, 2007

Actual Study Completion Date :

Feb 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama Hospital	Birmingham	Alabama	United States	35294
2	Osteoporosis Diagnostic Center	Eureka	California	United States	95503
3	Sharp Grossmont Hosptial	La Mesa	California	United States	91942
4	The Permanente Group	Santa Rosa	California	United States	95403
5	Radiant Research Lake Worth	Lake Worth	Florida	United States	33461
6	Atlanta Resarch Center	Decatur	Georgia	United States	30033
7	United Osteoporosis Center Health Services	Gainesville	Georgia	United States	30501
8	Galesburg Orthopedic Services LTD	Galesburg	Illinois	United States	61401
9	Illinois Bone and Joint Institute	Morton Grove	Illinois	United States	60053
10	Mercy Arthritis and Osteoporosis Center	Des Moines	Iowa	United States	50322
11	Maine Medical Center Research Institute	Portland	Maine	United States	04101
12	University of Maryland School of Medicine	Baltimore	Maryland	United States	21201
13	Wayne State University, Div. of Endocrinology	Detroit	Michigan	United States	48201
14	Health East Osteoporosis Service	Woodbury	Minnesota	United States	55125
15	Highland Hospital	Rochester	New York	United States	14620
16	University of North Carolina Hospital	Chapel Hill	North Carolina	United States	27599
17	Duke University Health System	Durham	North Carolina	United States	27710
18	University Orthopaedics	Canfield	Ohio	United States	44406
19	Ohio State University	Columbus	Ohio	United States	43210
20	University of Pennsylvania Health System-Presbyterian Medical Center	Philadelphia	Pennsylvania	United States	19104
21	Saint Joseph Medical Center	West Reading	Pennsylvania	United States	19611
22	Saint Josephs	Warwick	Rhode Island	United States	02818
23	Palmetto Richland Memorial Hospital	Columbia	South Carolina	United States	29203
24	Seton Medical Center	Austin	Texas	United States	78705
25	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
26	Danville Regional Medical Center	Danville	Virginia	United States	24541
27	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53706
28	Novartis	Nuernberg		Germany