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

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

This study has been completed.

Study NCT00046254. Last updated on September 24, 2007. Information provided by Novartis

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture
Official Title ^†
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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	Significant reduction in rate of clinical fractures after surgical repair of hip fracture
Secondary Outcome Measure ^†	Increase in total hip and femoral neck BMDs
Condition ^†	Osteoporosis Hip Fracture
Intervention ^†	Drug: Zoledronic Acid
MEDLINE PMIDs
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Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	2127
Start Date ^†	February 2002
Completion Date
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.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Germany

Administrative Information Fields
NCT ID ^†	NCT00046254
Organization ID	CZOL446H2310
Secondary IDs ^††
Study Sponsor ^†	Novartis
Collaborators ^††
Investigators ^†
Information Provided By	Novartis
Verification Date	September 2007
First Received Date ^†	September 24, 2002
Last Updated Date	September 24, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.