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

This study has been completed.
Sponsor:
Information provided by:
Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00163137
First received: September 9, 2005
Last updated: August 10, 2011
Last verified: August 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

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
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, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00163137     History of Changes
Other Study ID Numbers: A2181030
Study First Received: September 9, 2005
Last Updated: August 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Raloxifene
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 26, 2014