CORAL: Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
Sponsor
Ligand Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00163137
Collaborator
(none)
540
72
3
29
7.5
0.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
540 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date
:
May 1, 2003
Actual Primary Completion Date
:
Oct 1, 2005
Actual Study Completion Date
:
Oct 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lasofoxifene 0.25 mg lasofoxifene 0.25 mg/day |
Drug: lasofoxifene
lasofoxifene 0.25mg
|
| Active Comparator: raloxifene raloxifene 60 mg/day |
Drug: raloxifene
raloxifene 60 mg/day
|
| Placebo Comparator: Placebo Placebo |
Drug: Placebo
0 mg/day
|
Outcome Measures
Primary Outcome Measures
- Spine BMD after 2 years [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 [Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
48 Years
to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Albany | California | United States | 94706 |
| 2 | Pfizer Investigational Site | Berkeley | California | United States | 94705 |
| 3 | Pfizer Investigational Site | La Jolla | California | United States | 92037 |
| 4 | Pfizer Investigational Site | La Jolla | California | United States | 92093-0659 |
| 5 | Pfizer Investigational Site | Oakland | California | United States | 94609 |
| 6 | Pfizer Investigational Site | Oakland | California | United States | 94612 |
| 7 | Pfizer Investigational Site | Palo Alto | California | United States | 94304 |
| 8 | Pfizer Investigational Site | Poway | California | United States | 92064 |
| 9 | Pfizer Investigational Site | San Diego | California | United States | 92103 |
| 10 | Pfizer Investigational Site | San Diego | California | United States | 92123 |
| 11 | Pfizer Investigational Site | San Diego | California | United States | 92128 |
| 12 | Pfizer Investigational Site | Newark | Delaware | United States | 19713-2094 |
| 13 | Pfizer Investigational Site | Brandon | Florida | United States | 33511-5964 |
| 14 | Pfizer Investigational Site | Gainesville | Florida | United States | 32605 |
| 15 | Pfizer Investigational Site | Gainesville | Florida | United States | 32607 |
| 16 | Pfizer Investigational Site | Key Largo | Florida | United States | 33037 |
| 17 | Pfizer Investigational Site | Lake Worth | Florida | United States | 33461 |
| 18 | Pfizer Investigational Site | Leesburg | Florida | United States | 34748 |
| 19 | Pfizer Investigational Site | Miami | Florida | United States | 33143 |
| 20 | Pfizer Investigational Site | Miami | Florida | United States | 33173 |
| 21 | Pfizer Investigational Site | Miami | Florida | United States | 33176 |
| 22 | Pfizer Investigational Site | Tampa | Florida | United States | 33607 |
| 23 | Pfizer Investigational Site | Tampa | Florida | United States | 33613-3946 |
| 24 | Pfizer Investigational Site | Tampa | Florida | United States | 33614-7118 |
| 25 | Pfizer Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 26 | Pfizer Investigational Site | Atlanta | Georgia | United States | 30308 |
| 27 | Pfizer Investigational Site | Chicago | Illinois | United States | 60610 |
| 28 | Pfizer Investigational Site | Des Moines | Iowa | United States | 50309 |
| 29 | Pfizer Investigational Site | Wichita | Kansas | United States | 67207 |
| 30 | Pfizer Investigational Site | Portland | Maine | United States | 04102 |
| 31 | Pfizer Investigational Site | Bethesda | Maryland | United States | 20817 |
| 32 | Pfizer Investigational Site | Gaithersberg | Maryland | United States | 20886 |
| 33 | Pfizer Investigational Site | Detroit | Michigan | United States | 48201 |
| 34 | Pfizer Investigational Site | Detroit | Michigan | United States | 48236 |
| 35 | Pfizer Investigational Site | Southfield | Michigan | United States | 48034 |
| 36 | Pfizer Investigational Site | Arden Hills | Minnesota | United States | 55112 |
| 37 | Pfizer Investigational Site | Minneapolis | Minnesota | United States | 55415-1226 |
| 38 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 39 | Pfizer Investigational Site | Albuquerque | New Mexico | United States | 87106 |
| 40 | Pfizer Investigational Site | Akron | Ohio | United States | 44312-1647 |
| 41 | Pfizer Investigational Site | Akron | Ohio | United States | 44314 |
| 42 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44195 |
| 43 | Pfizer Investigational Site | Portland | Oregon | United States | 97213 |
| 44 | Pfizer Investigational Site | Portland | Oregon | United States | 97220 |
| 45 | Pfizer Investigational Site | Monessen | Pennsylvania | United States | 15062 |
| 46 | Pfizer Investigational Site | Mosessen | Pennsylvania | United States | 15062 |
| 47 | Pfizer Investigational Site | Pittsburgh | Pennsylvania | United States | 15213 |
| 48 | Pfizer Investigational Site | West Reading | Pennsylvania | United States | 19611 |
| 49 | Pfizer Investigational Site | Wyomissing | Pennsylvania | United States | 19610-2132 |
| 50 | Pfizer Investigational Site | Wyomissing | Pennsylvania | United States | 19610 |
| 51 | Pfizer Investigational Site | Chattanooga | Tennessee | United States | 37403 |
| 52 | Pfizer Investigational Site | Chattanooga | Tennessee | United States | 37412 |
| 53 | Pfizer Investigational Site | Cordova | Tennessee | United States | 38018 |
| 54 | Pfizer Investigational Site | Germantown | Tennessee | United States | 38138 |
| 55 | Pfizer Investigational Site | Memphis | Tennessee | United States | 38119 |
| 56 | Pfizer Investigational Site | Nashville | Tennessee | United States | 37203 |
| 57 | Pfizer Investigational Site | Dallas | Texas | United States | 75230 |
| 58 | Pfizer Investigational Site | American Fork | Utah | United States | 84003 |
| 59 | Pfizer Investigational Site | Pleasant Grove | Utah | United States | 84062 |
| 60 | Pfizer Investigational Site | Provo | Utah | United States | 84064 |
| 61 | Pfizer Investigational Site | Salt Lake City | Utah | United States | 84102 |
| 62 | Pfizer Investigational Site | West Jordan | Utah | United States | 84088 |
| 63 | Pfizer Investigational Site | Chesapeake | Virginia | United States | 23320 |
| 64 | Pfizer Investigational Site | Norfolk | Virginia | United States | 23502 |
| 65 | Pfizer Investigational Site | Richmond | Virginia | United States | 23221 |
| 66 | Pfizer Investigational Site | Richmond | Virginia | United States | 23225 |
| 67 | Pfizer Investigational Site | Richmond | Virginia | United States | 23229 |
| 68 | Pfizer Investigational Site | Richmond | Virginia | United States | 23294 |
| 69 | Pfizer Investigational Site | Richmond | Virginia | United States | 23454 |
| 70 | Pfizer Investigational Site | Virginia Beach | Virginia | United States | 23454 |
| 71 | Pfizer Investigational Site | Seattle | Washington | United States | 98104 |
| 72 | Pfizer Investigational Site | Seattle | Washington | United States | 98144 |
Sponsors and Collaborators
- Ligand Pharmaceuticals
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00163137
Other Study ID Numbers:
- A2181030
First Posted:
Sep 13, 2005
Last Update Posted:
Aug 12, 2011
Last Verified:
Aug 1, 2011