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CORAL: Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
This study has been completed.
First Received: September 9, 2005   Last Updated: July 23, 2006   History of Changes
Sponsor: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00163137
  Purpose

To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60 mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.


Condition Intervention Phase
Osteoporosis
 Drug: lasofoxifene
Drug: raloxifene
Drug: placebo
 Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Md/D and Raloxifene 60mg/D For The Prevention Of Bone Loss In Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
Drug Information available for: Raloxifene hydrochloride Raloxifene Lasofoxifene
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Spine BMD after 2 years

Secondary Outcome Measures:
  • Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year

Estimated Enrollment: 500
Study Start Date: May 2003
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   48 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings

Exclusion Criteria:

  • Presence of metabolic bone disease, fractures, blood clots, or recent cancer.
  • Any use of selective estrogen receptor modulators, investigational drugs, or recent use of osteoporosis treatments, certain hormones, or medication for blood clots or seizures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163137

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Palo Alto, California, United States, 94304
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
La Jolla, California, United States, 92093-0659
Pfizer Investigational Site
Poway, California, United States, 92064
Pfizer Investigational Site
Oakland, California, United States, 94609
Pfizer Investigational Site
San Diego, California, United States, 92128
Pfizer Investigational Site
Albany, California, United States, 94706
Pfizer Investigational Site
Berkeley, California, United States, 94705
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Oakland, California, United States, 94612
Pfizer Investigational Site
San Diego, California, United States, 92123
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713-2094
United States, Florida
Pfizer Investigational Site
Key Largo, Florida, United States, 33037
Pfizer Investigational Site
Miami, Florida, United States, 33173
Pfizer Investigational Site
Gainesville, Florida, United States, 32607
Pfizer Investigational Site
MIAMI, Florida, United States, 33143
Pfizer Investigational Site
Gainesville, Florida, United States, 32605
Pfizer Investigational Site
Miami, Florida, United States, 33176
Pfizer Investigational Site
Lake Worth, Florida, United States, 33461
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
Pfizer Investigational Site
Leesburg, Florida, United States, 34748
Pfizer Investigational Site
Brandon, Florida, United States, 33511-5964
Pfizer Investigational Site
Tampa, Florida, United States, 33607
Pfizer Investigational Site
Tampa, Florida, United States, 33613-3946
Pfizer Investigational Site
Tampa, Florida, United States, 33614-7118
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60610
United States, Iowa
Pfizer Investigational Site
Des Moines, Iowa, United States, 50309
United States, Kansas
Pfizer Investigational Site
Wichita, Kansas, United States, 67207
United States, Maine
Pfizer Investigational Site
Portland, Maine, United States, 04102
United States, Maryland
Pfizer Investigational Site
Bethesda, Maryland, United States, 20817
Pfizer Investigational Site
Gaithersberg, Maryland, United States, 20886
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48236
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Southfield, Michigan, United States, 48034
United States, Minnesota
Pfizer Investigational Site
Arden Hills, Minnesota, United States, 55112
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55415-1226
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44312-1647
Pfizer Investigational Site
Akron, Ohio, United States, 44314
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97213
Pfizer Investigational Site
Portland, Oregon, United States, 97220
United States, Pennsylvania
Pfizer Investigational Site
Monessen, Pennsylvania, United States, 15062
Pfizer Investigational Site
Mosessen, Pennsylvania, United States, 15062
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Pfizer Investigational Site
West Reading, Pennsylvania, United States, 19611
Pfizer Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Pfizer Investigational Site
WYOMISSING, Pennsylvania, United States, 19610-2132
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Cordova, Tennessee, United States, 38018
Pfizer Investigational Site
Germantown, Tennessee, United States, 38138
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37403
Pfizer Investigational Site
Chattanooga, Tennessee, United States, 37412
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75230
United States, Utah
Pfizer Investigational Site
American Fork, Utah, United States, 84003
Pfizer Investigational Site
Pleasant Grove, Utah, United States, 84062
Pfizer Investigational Site
Provo, Utah, United States, 84064
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84102
Pfizer Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
Pfizer Investigational Site
Chesapeake, Virginia, United States, 23320
Pfizer Investigational Site
Norfolk, Virginia, United States, 23502
Pfizer Investigational Site
Richmond, Virginia, United States, 23221
Pfizer Investigational Site
Richmond, Virginia, United States, 23225
Pfizer Investigational Site
Richmond, Virginia, United States, 23229
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
Pfizer Investigational Site
Richmond, Virginia, United States, 23454
Pfizer Investigational Site
Virginia Beach, Virginia, United States, 23454
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Seattle, Washington, United States, 98144
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Study ID Numbers: A2181030
Study First Received: September 9, 2005
Last Updated: July 23, 2006
ClinicalTrials.gov Identifier: NCT00163137     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

ClinicalTrials.gov processed this record on November 25, 2009



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