Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss - Full Text View

Sponsor:	Ligand Pharmaceuticals
Information provided by:	Ligand Pharmaceuticals
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:	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:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Raloxifene hydrochloride Raloxifene Lasofoxifene

U.S. FDA Resources

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

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 February 13, 2012