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

This study has been completed.

First Received: September 9, 2005 Last Updated: July 23, 2006 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00163137

Purpose

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	Intervention	Phase
Osteoporosis	Drug: lasofoxifene Drug: raloxifene Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Raloxifene hydrochloride Raloxifene Lasofoxifene

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Spine BMD after 2 years

Secondary Outcome Measures:

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

Estimated Enrollment:	500
Study Start Date:	May 2003
Estimated Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	48 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163137

Show 72 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

Study ID Numbers:	A2181030
Study First Received:	September 9, 2005
Last Updated:	July 23, 2006
ClinicalTrials.gov Identifier:	NCT00163137 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Estrogens
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Bone Diseases
Hormones
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases

Additional relevant MeSH terms:

Estrogen Antagonists
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Bone Density Conservation Agents

Selective Estrogen Receptor Modulators
Bone Diseases
Pharmacologic Actions
Estrogen Receptor Modulators
Raloxifene
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 02, 2009