Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
CORAL
Double-Blind Placebo-Controlled Trial Of The Safety, Toleration and Efficacy Of Lasofoxifene 0.25 Mg/D and Raloxifene 60Mg/D For The Prevention Of Bone Loss In Postmenopausal Women
1 other identifier
interventional
540
1 country
72
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2003
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedAugust 12, 2011
August 1, 2011
2.4 years
September 9, 2005
August 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Spine BMD after 2 years
Lumbar Spine Bome Mineral Density
2 years
Secondary Outcomes (1)
Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months
Study Arms (3)
Lasofoxifene 0.25 mg
EXPERIMENTALlasofoxifene 0.25 mg/day
raloxifene
ACTIVE COMPARATORraloxifene 60 mg/day
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Pfizer Investigational Site
Albany, California, 94706, United States
Pfizer Investigational Site
Berkeley, California, 94705, United States
Pfizer Investigational Site
La Jolla, California, 92037, United States
Pfizer Investigational Site
La Jolla, California, 92093-0659, United States
Pfizer Investigational Site
Oakland, California, 94609, United States
Pfizer Investigational Site
Oakland, California, 94612, United States
Pfizer Investigational Site
Palo Alto, California, 94304, United States
Pfizer Investigational Site
Poway, California, 92064, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
San Diego, California, 92123, United States
Pfizer Investigational Site
San Diego, California, 92128, United States
Pfizer Investigational Site
Newark, Delaware, 19713-2094, United States
Pfizer Investigational Site
Brandon, Florida, 33511-5964, United States
Pfizer Investigational Site
Gainesville, Florida, 32605, United States
Pfizer Investigational Site
Gainesville, Florida, 32607, United States
Pfizer Investigational Site
Key Largo, Florida, 33037, United States
Pfizer Investigational Site
Lake Worth, Florida, 33461, United States
Pfizer Investigational Site
Leesburg, Florida, 34748, United States
Pfizer Investigational Site
Miami, Florida, 33143, United States
Pfizer Investigational Site
Miami, Florida, 33173, United States
Pfizer Investigational Site
Miami, Florida, 33176, United States
Pfizer Investigational Site
Tampa, Florida, 33607, United States
Pfizer Investigational Site
Tampa, Florida, 33613-3946, United States
Pfizer Investigational Site
Tampa, Florida, 33614-7118, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33407, United States
Pfizer Investigational Site
Atlanta, Georgia, 30308, United States
Pfizer Investigational Site
Chicago, Illinois, 60610, United States
Pfizer Investigational Site
Des Moines, Iowa, 50309, United States
Pfizer Investigational Site
Wichita, Kansas, 67207, United States
Pfizer Investigational Site
Portland, Maine, 04102, United States
Pfizer Investigational Site
Bethesda, Maryland, 20817, United States
Pfizer Investigational Site
Gaithersberg, Maryland, 20886, United States
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
Pfizer Investigational Site
Detroit, Michigan, 48236, United States
Pfizer Investigational Site
Southfield, Michigan, 48034, United States
Pfizer Investigational Site
Arden Hills, Minnesota, 55112, United States
Pfizer Investigational Site
Minneapolis, Minnesota, 55415-1226, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87102, United States
Pfizer Investigational Site
Albuquerque, New Mexico, 87106, United States
Pfizer Investigational Site
Akron, Ohio, 44312-1647, United States
Pfizer Investigational Site
Akron, Ohio, 44314, United States
Pfizer Investigational Site
Cleveland, Ohio, 44195, United States
Pfizer Investigational Site
Portland, Oregon, 97213, United States
Pfizer Investigational Site
Portland, Oregon, 97220, United States
Pfizer Investigational Site
Monessen, Pennsylvania, 15062, United States
Pfizer Investigational Site
Mosessen, Pennsylvania, 15062, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site
West Reading, Pennsylvania, 19611, United States
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610-2132, United States
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Pfizer Investigational Site
Chattanooga, Tennessee, 37403, United States
Pfizer Investigational Site
Chattanooga, Tennessee, 37412, United States
Pfizer Investigational Site
Cordova, Tennessee, 38018, United States
Pfizer Investigational Site
Germantown, Tennessee, 38138, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Nashville, Tennessee, 37203, United States
Pfizer Investigational Site
Dallas, Texas, 75230, United States
Pfizer Investigational Site
American Fork, Utah, 84003, United States
Pfizer Investigational Site
Pleasant Grove, Utah, 84062, United States
Pfizer Investigational Site
Provo, Utah, 84064, United States
Pfizer Investigational Site
Salt Lake City, Utah, 84102, United States
Pfizer Investigational Site
West Jordan, Utah, 84088, United States
Pfizer Investigational Site
Chesapeake, Virginia, 23320, United States
Pfizer Investigational Site
Norfolk, Virginia, 23502, United States
Pfizer Investigational Site
Richmond, Virginia, 23221, United States
Pfizer Investigational Site
Richmond, Virginia, 23225, United States
Pfizer Investigational Site
Richmond, Virginia, 23229, United States
Pfizer Investigational Site
Richmond, Virginia, 23294, United States
Pfizer Investigational Site
Richmond, Virginia, 23454, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23454, United States
Pfizer Investigational Site
Seattle, Washington, 98104, United States
Pfizer Investigational Site
Seattle, Washington, 98144, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 13, 2005
Study Start
May 1, 2003
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
August 12, 2011
Record last verified: 2011-08