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

Condition(s) targeted: Osteoporosis

Intervention: lasofoxifene (Drug); raloxifene (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Spine BMD after 2 years

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

Minimum age: 48 Years. Maximum age: 75 Years. Gender(s): Female.

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.

Pfizer Investigational Site, Palo Alto, California 94304, United States

Pfizer Investigational Site, La Jolla, California 92037, United States

Pfizer Investigational Site, La Jolla, California 92093-0659, 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 92128, United States

Pfizer Investigational Site, Albany, California 94706, United States

Pfizer Investigational Site, Berkeley, California 94705, United States

Pfizer Investigational Site, Oakland, California 94609, United States

Pfizer Investigational Site, Oakland, California 94612, United States

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Newark, Delaware 19713-2094, United States

Pfizer Investigational Site, Key Largo, Florida 33037, United States

Pfizer Investigational Site, Miami, Florida 33173, United States

Pfizer Investigational Site, Miami, Florida 33176, United States

Pfizer Investigational Site, MIAMI, Florida 33143, United States

Pfizer Investigational Site, Gainesville, Florida 32605, United States

Pfizer Investigational Site, Gainesville, Florida 32607, United States

Pfizer Investigational Site, Lake Worth, Florida 33461, United States

Pfizer Investigational Site, West Palm Beach, Florida 33407, United States

Pfizer Investigational Site, Leesburg, Florida 34748, United States

Pfizer Investigational Site, Brandon, Florida 33511-5964, 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, 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 48236, United States

Pfizer Investigational Site, Detroit, Michigan 48201, 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, United States

Pfizer Investigational Site, WYOMISSING, Pennsylvania 19610-2132, United States

Pfizer Investigational Site, Nashville, Tennessee 37203, 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, Chattanooga, Tennessee 37403, United States

Pfizer Investigational Site, Chattanooga, Tennessee 37412, 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

Starting date: May 2003
Ending date: October 2005
Last updated: July 23, 2006