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

Tracking Information
First Received Date ^ICMJE	September 24, 2002
Last Updated Date	September 24, 2007
Start Date ^ICMJE	February 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00046254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 30, 2006)	Increase in total hip and femoral neck BMDs
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
Official Title ^ICMJE
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
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Osteoporosis Hip Fracture
Intervention ^ICMJE	Drug: Zoledronic Acid
Study Arms / Comparison Groups
Publications *	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. Epub 2007 Sep 17.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	2127
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Germany

Administrative Information
NCT ID ^ICMJE	NCT00046254
Responsible Party
Study ID Numbers ^ICMJE	CZOL446H2310
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	September 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP