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

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ClinicalTrials.gov Identifier: NCT00163137
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : August 12, 2011
Sponsor:
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

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
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Raloxifene
U.S. FDA Resources

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
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.



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Ages Eligible for Study:   48 Years to 75 Years   (Adult, Senior)
Sexes 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.

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 ClinicalTrials.gov identifier (NCT number): NCT00163137


  Show 72 Study Locations
Sponsors and Collaborators
Ligand Pharmaceuticals
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00163137     History of Changes
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:
Osteoporosis
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