Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis - Tabular View

Tracking Information
First Received Date ^ICMJE	September 20, 2002
Last Updated Date	July 19, 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 NCT00046137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis
Official Title ^ICMJE
Brief Summary	The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the two drugs and may help to determine whether teriparatide and raloxifene together can help patients with osteoporosis more than teriparatide alone.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Osteoporosis, Postmenopausal
Intervention ^ICMJE	Drug: teriparatide Drug: raloxifene Drug: placebo
Study Arms / Comparison Groups
Publications *
* 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 Must be diagnosed with osteoporosis. Must be female, age 45 through 85. Must be at least 5 years postmenopausal. Must be free of other severe or chronically disabling conditions. Must be able to properly use injection device. Exclusion Criteria Must not have bone diseases other than osteoporosis. Must not have history of certain cancers. Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes). Must not have taken or are currently taking certain types of medicines. Must not have known allergy to the study agent or SERM.
Gender	Female
Ages	45 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00046137
Responsible Party
Study ID Numbers ^ICMJE	6817, B3D-MC-GHCD
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