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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

July 23, 2006

Start Date ^ICMJE

May 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Spine BMD after 2 years

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00163137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoporosis

Intervention ^ICMJE

Drug: lasofoxifene
Drug: raloxifene
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

48 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00163137

Responsible Party

Study ID Numbers ^ICMJE

A2181030

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP