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

NCT ID: NCT00163137

Last Updated: 2011-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lasofoxifene 0.25 mg

lasofoxifene 0.25 mg/day

Group Type EXPERIMENTAL

lasofoxifene

Intervention Type DRUG

lasofoxifene 0.25mg

raloxifene

raloxifene 60 mg/day

Group Type ACTIVE_COMPARATOR

raloxifene

Intervention Type DRUG

raloxifene 60 mg/day

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg/day

Interventions

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lasofoxifene

lasofoxifene 0.25mg

Intervention Type DRUG

raloxifene

raloxifene 60 mg/day

Intervention Type DRUG

Placebo

0 mg/day

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

48 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ligand Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Ligand Pharmaceuticals

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Albany, California, United States

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Berkeley, California, United States

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La Jolla, California, United States

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La Jolla, California, United States

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Oakland, California, United States

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Oakland, California, United States

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Palo Alto, California, United States

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Poway, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Newark, Delaware, United States

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Brandon, Florida, United States

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Gainesville, Florida, United States

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Gainesville, Florida, United States

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Key Largo, Florida, United States

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Lake Worth, Florida, United States

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Leesburg, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Portland, Maine, United States

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Bethesda, Maryland, United States

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Gaithersberg, Maryland, United States

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Detroit, Michigan, United States

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Detroit, Michigan, United States

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Southfield, Michigan, United States

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Arden Hills, Minnesota, United States

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Minneapolis, Minnesota, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Akron, Ohio, United States

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Akron, Ohio, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Monessen, Pennsylvania, United States

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Mosessen, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Wyomissing, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Chattanooga, Tennessee, United States

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Cordova, Tennessee, United States

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Germantown, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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American Fork, Utah, United States

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Pleasant Grove, Utah, United States

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Provo, Utah, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Chesapeake, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Countries

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United States

Other Identifiers

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A2181030

Identifier Type: -

Identifier Source: org_study_id

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