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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00163137
First Posted: September 13, 2005
Last Update Posted: August 12, 2011
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.
Information provided by:
Ligand Pharmaceuticals
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ligand Pharmaceuticals:

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


Secondary Outcome Measures:
  • 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.


Enrollment: 540
Study Start Date: May 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
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
  More Information

Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00163137     History of Changes
Other Study ID Numbers: A2181030
First Submitted: September 9, 2005
First Posted: September 13, 2005
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