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EVA: Evista Alendronate Comparison
This study has been completed.
First Received: May 7, 2002   Last Updated: July 18, 2006   History of Changes
Sponsor: Eli Lilly and Company
Information provided by: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00035971
  Purpose

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


Condition Intervention Phase
Osteoporosis
 Drug: raloxifene HCI and alendronate Na
 Phase IV

Study Type: Interventional
Study Design: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
Drug Information available for: Alendronate Raloxifene hydrochloride Raloxifene Alendronate sodium Fosamax
U.S. FDA Resources
  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00035971

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Locations
United States, Alabama
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Anniston, Alabama, United States
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Tucson, Arizona, United States
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Scottsdale, Arizona, United States
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Phoenix, Arizona, United States
United States, California
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Loma Linda, California, United States
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Oakland, California, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Walnut Creek, California, United States
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Lakewood, Colorado, United States
United States, Connecticut
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Trumbull, Connecticut, United States
United States, Florida
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Miami, Florida, United States
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Maitland, Florida, United States
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Riverdale, Georgia, United States
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Idaho Falls, Idaho, United States
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Peoria, Illinois, United States
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Des Moines, Iowa, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Bangor, Maine, United States
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Frederick, Maryland, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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Springfield, Missouri, United States
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Bronx, New York, United States
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Greenville, North Carolina, United States
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Providence, Rhode Island, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Richmond, Virginia, United States
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Newport News, Virginia, United States
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Calgary, Alberta, Canada
Canada, British Columbia
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Vancouver, British Columbia, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, New Brunswick
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Moncton, New Brunswick, Canada
Canada, Ontario
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Burlington, Ontario, Canada
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Hamilton, Ontario, Canada
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Kitchener, Ontario, Canada
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Ottawa, Ontario, Canada
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Sudbury, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
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Sainte Foy, Quebec, Canada
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Trois-Rivieres, Quebec, Canada
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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.

Study ID Numbers: 5548, H3S-US-GGKO
Study First Received: May 7, 2002
Last Updated: July 18, 2006
ClinicalTrials.gov Identifier: NCT00035971     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents
 Selective Estrogen Receptor Modulators
Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases
Alendronate

ClinicalTrials.gov processed this record on November 25, 2009



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