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

Ligand Pharmaceuticals540 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

540

Conditions

Osteoporosis

Interventions

lasofoxifeneDRUG

lasofoxifene 0.25mg

raloxifeneDRUG

raloxifene 60 mg/day

PlaceboDRUG

0 mg/day

Eligibility

Sex: FEMALEMin age: 48 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (72)

Outcomes

Primary Outcomes

Spine BMD after 2 years

Lumbar Spine Bome Mineral Density

Time frame: 2 years

Secondary Outcomes

Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year

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.

Time frame: Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months

Data from ClinicalTrials.gov

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San Diego, California, United States

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San Diego, California, United States

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