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Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss (CORAL)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lasofoxifene
raloxifene
Placebo
Sponsored by
Ligand Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

48 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lasofoxifene 0.25 mg

raloxifene

Placebo

Arm Description

lasofoxifene 0.25 mg/day

raloxifene 60 mg/day

Placebo

Outcomes

Primary Outcome Measures

Spine BMD after 2 years
Lumbar Spine Bome Mineral Density

Secondary Outcome Measures

Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Direct low density lipoprotein cholesterol (LDL-C) at 24 months, vaginal pH at 24 months, vaginal epithelial parabasal cells at 12 months, and total hip BMD at 24 months.

Full Information

First Posted
September 9, 2005
Last Updated
August 10, 2011
Sponsor
Ligand Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00163137
Brief Title
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
Acronym
CORAL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ligand Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lasofoxifene 0.25 mg
Arm Type
Experimental
Arm Description
lasofoxifene 0.25 mg/day
Arm Title
raloxifene
Arm Type
Active Comparator
Arm Description
raloxifene 60 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
lasofoxifene
Intervention Description
lasofoxifene 0.25mg
Intervention Type
Drug
Intervention Name(s)
raloxifene
Intervention Description
raloxifene 60 mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0 mg/day
Primary Outcome Measure Information:
Title
Spine BMD after 2 years
Description
Lumbar Spine Bome Mineral Density
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Description
Direct low density lipoprotein cholesterol (LDL-C) at 24 months, vaginal pH at 24 months, vaginal epithelial parabasal cells at 12 months, and total hip BMD at 24 months.
Time Frame
Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Albany
State/Province
California
ZIP/Postal Code
94706
Country
United States
Facility Name
Pfizer Investigational Site
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0659
Country
United States
Facility Name
Pfizer Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Pfizer Investigational Site
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Pfizer Investigational Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Pfizer Investigational Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Pfizer Investigational Site
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713-2094
Country
United States
Facility Name
Pfizer Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511-5964
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Pfizer Investigational Site
City
Key Largo
State/Province
Florida
ZIP/Postal Code
33037
Country
United States
Facility Name
Pfizer Investigational Site
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Pfizer Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-3946
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7118
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Pfizer Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Pfizer Investigational Site
City
Gaithersberg
State/Province
Maryland
ZIP/Postal Code
20886
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Pfizer Investigational Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Pfizer Investigational Site
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Facility Name
Pfizer Investigational Site
City
Arden Hills
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415-1226
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Pfizer Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44312-1647
Country
United States
Facility Name
Pfizer Investigational Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44314
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Pfizer Investigational Site
City
Monessen
State/Province
Pennsylvania
ZIP/Postal Code
15062
Country
United States
Facility Name
Pfizer Investigational Site
City
Mosessen
State/Province
Pennsylvania
ZIP/Postal Code
15062
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pfizer Investigational Site
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Pfizer Investigational Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610-2132
Country
United States
Facility Name
Pfizer Investigational Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Pfizer Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Pfizer Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37412
Country
United States
Facility Name
Pfizer Investigational Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Pfizer Investigational Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Pfizer Investigational Site
City
Pleasant Grove
State/Province
Utah
ZIP/Postal Code
84062
Country
United States
Facility Name
Pfizer Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84064
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Pfizer Investigational Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Pfizer Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Pfizer Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23221
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Pfizer Investigational Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss

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