EVA: Evista Alendronate Comparison

July 18, 2006 updated by: Eli Lilly and Company

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

Study Overview

Status

Completed

Conditions

Osteoporosis

Intervention / Treatment

Drug: raloxifene HCI and alendronate Na

Study Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- British Columbia
  - Vancouver, British Columbia, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Manitoba
  - Winnipeg, Manitoba, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- New Brunswick
  - Moncton, New Brunswick, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Ontario
  - Burlington, Ontario, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Hamilton, Ontario, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Kitchener, Ontario, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Ottawa, Ontario, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Sudbury, Ontario, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Quebec
  - Montreal, Quebec, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Sainte Foy, Quebec, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Trois-Rivieres, Quebec, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
United States
- Alabama
  - Anniston, Alabama, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Arizona
  - Phoenix, Arizona, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Scottsdale, Arizona, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Tucson, Arizona, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- California
  - Anaheim, California, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Beverly Hills, California, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Loma Linda, California, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Oakland, California, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - San Francisco, California, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Walnut Creek, California, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Colorado
  - Lakewood, Colorado, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Connecticut
  - Trumbull, Connecticut, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Florida
  - Maitland, Florida, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Miami, Florida, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Tampa, Florida, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - West Palm Beach, Florida, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Georgia
  - Decatur, Georgia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Fayetteville, Georgia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Gainesville, Georgia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Riverdale, Georgia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Hawaii
  - Honolulu, Hawaii, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Idaho
  - Boise, Idaho, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Idaho Falls, Idaho, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Illinois
  - Chicago, Illinois, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Morton Grove, Illinois, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Peoria, Illinois, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Indiana
  - Evansville, Indiana, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Indianapolis, Indiana, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Iowa
  - Des Moines, Iowa, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Kansas
  - Overland Park, Kansas, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Kentucky
  - Lexington, Kentucky, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Maine
  - Bangor, Maine, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Maryland
  - Frederick, Maryland, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Hagerstown, Maryland, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Massachusetts
  - Boston, Massachusetts, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Michigan
  - Detroit, Michigan, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Minnesota
  - Minneapolis, Minnesota, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Missouri
  - Springfield, Missouri, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - St. Louis, Missouri, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Nebraska
  - Omaha, Nebraska, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- New Hampshire
  - Lebanon, New Hampshire, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- New Jersey
  - Passaic, New Jersey, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- New Mexico
  - Albuquerque, New Mexico, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- New York
  - Albany, New York, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Bronx, New York, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - New York, New York, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Rochester, New York, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- North Carolina
  - Charlotte, North Carolina, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Greensboro, North Carolina, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Greenville, North Carolina, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Morehead City, North Carolina, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Ohio
  - Beachwood, Ohio, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Canton, Ohio, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Cincinnati, Ohio, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Oklahoma
  - Tulsa, Oklahoma, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Oregon
  - Portland, Oregon, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Pennsylvania
  - Philadelphia, Pennsylvania, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Pittsburgh, Pennsylvania, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
- Rhode Island
  - Johnston, Rhode Island, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Providence, Rhode Island, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Texas
  - Austin, Texas, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - Dallas, Texas, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
  - San Antonio, Texas, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Temple, Texas, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559 or speak with your personal physician.
- Utah
  - Salt Lake City, Utah, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Vermont
  - Burlington, Vermont, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Virginia
  - Charlottesville, Virginia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Newport News, Virginia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Richmond, Virginia, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Washington
  - Seattle, Washington, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Spokane, Washington, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
  - Tacoma, Washington, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
- Wisconsin
  - Madison, Wisconsin, United States
    - For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1016/j.bone.2006.11.001. Epub 2006 Dec 19.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 6, 2022

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Study Registration Dates

First Submitted

May 7, 2002

First Submitted That Met QC Criteria

May 7, 2002

First Posted (Estimate)

May 8, 2002

Study Record Updates

Last Update Posted (Estimate)

July 19, 2006

Last Update Submitted That Met QC Criteria

July 18, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

5548
H3S-US-GGKO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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EVA: Evista Alendronate Comparison

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start

Primary Completion

Study Completion

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Osteoporosis

Clinical Trials on raloxifene HCI and alendronate Na

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

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Conditions

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Locations