COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00163137
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : August 12, 2011
Information provided by:
Ligand Pharmaceuticals

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
Osteoporosis Drug: lasofoxifene Drug: raloxifene Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 2003
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Raloxifene

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
Drug: Placebo
0 mg/day

Primary Outcome Measures :
  1. Spine BMD after 2 years [ Time Frame: 2 years ]
    Lumbar Spine Bome Mineral Density

Secondary Outcome Measures :
  1. Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   48 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00163137

Show Show 72 study locations
Sponsors and Collaborators
Ligand Pharmaceuticals
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer
Layout table for additonal information
Responsible Party: Director, Project Management, Ligand Pharmaceuticals Identifier: NCT00163137    
Other Study ID Numbers: A2181030
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Raloxifene Hydrochloride
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents