HORIZON-PFT: Pivotal Fracture Trial - Tabular View

Tracking Information
First Received Date ^ICMJE	November 14, 2002
Last Updated Date	October 9, 2007
Start Date ^ICMJE	January 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 29, 2006)	Incidence of hip fxs Incidence of new vertebral fxs
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00049829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 29, 2006)	Percent change in hip BMD New and/or worsening vertebral fxs All clinical fxs
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	HORIZON-PFT: Pivotal Fracture Trial
Official Title ^ICMJE	HORIZON-PFT: Pivotal Fracture Trial
Brief Summary	HORIZON-PFT (Pivotal Fracture Trial) will study the effect of zoledronic acid, given once per year, on the treatment of osteoporosis in women past menopause. Hip and vertebral fractures are the most devastating consequences of osteoporosis. HORIZON-PFT is designed to determine the benefits of zoledronic acid in fracture reduction at both the hip and spine.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Osteoporosis
Intervention ^ICMJE	Drug: Zoledronic Acid
Study Arms / Comparison Groups
Publications *	Eastell R, Black DM, Boonen S, Adami S, Felsenberg D, Lippuner K, Cummings SR, Delmas PD, Palermo L, Mesenbrink P, Cauley JA; HORIZON Pivotal Fracture Trial. Effect of once-yearly zoledronic acid five milligrams on fracture risk and change in femoral neck bone mineral density. J Clin Endocrinol Metab. 2009 Sep;94(9):3215-25. Epub 2009 Jun 30. Black DM, Delmas PD, Eastell R, Reid IR, Boonen S, Cauley JA, Cosman F, Lakatos P, Leung PC, Man Z, Mautalen C, Mesenbrink P, Hu H, Caminis J, Tong K, Rosario-Jansen T, Krasnow J, Hue TF, Sellmeyer D, Eriksen EF, Cummings SR; HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med. 2007 May 3;356(18):1809-22.
* 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	7700
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Female, 65-89 years old No history of severe liver, kidney or eye disease Exclusion Criteria: Current bisphosphonate users such as Aredia® (pamidronate), Didronel® (etidronate), Fosamax® (alendronate), Actonel® (risedronate), Skelid® (tiludronate) Using hip protectors Other protocol-defined inclusion/exclusion criteria may apply.
Gender	Female
Ages	65 Years to 89 Years
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	NCT00049829
Responsible Party
Study ID Numbers ^ICMJE	CZOL446H2301
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Novartis
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP