EVA: Evista Alendronate Comparison - Tabular View

Tracking Information
First Received Date ^ICMJE	May 7, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	EVA: Evista Alendronate Comparison
Official Title ^ICMJE
Brief Summary	The purpose of this study is to determine how treatment with raloxifene compares to treatment with alendronate in postmenopausal women with osteoporosis on the chance of experiencing fractures
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Osteoporosis
Intervention ^ICMJE	Drug: raloxifene HCI and alendronate Na
Study Arms / Comparison Groups
Publications *	Recker RR, Kendler D, Recknor CP, Rooney TW, Lewiecki EM, Utian WH, Cauley JA, Lorraine J, Qu Y, Kulkarni PM, Gaich CL, Wong M, Plouffe L Jr, Stock JL. Comparative effects of raloxifene and alendronate on fracture outcomes in postmenopausal women with low bone mass. Bone. 2007 Apr;40(4):843-51. Epub 2006 Dec 19.
* 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
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria 50-80 years of age, inclusive 2 years since last menses Dx femoral neck osteoporosis No vertebral fractures Exclusion Criteria Poor candidate for study drugs Hx of diseases affecting bone metabolism Hx of breast/estrogen-dependent cancer Current use of osteoporosis drug therapy Hx/high risk of VTE
Gender	Female
Ages	50 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00035971
Responsible Party
Study ID Numbers ^ICMJE	5548, H3S-US-GGKO
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP