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

Ligand Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: lasofoxifene; Drug: Placebo; Drug: raloxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00163137

A2181030

Details and patient eligibility

About

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.

Enrollment: 540 patients

Sex: Female

Ages: 48 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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540 participants in 3 patient groups, including a placebo group

Lasofoxifene 0.25 mg

Experimental group

Description:

lasofoxifene 0.25 mg/day

Treatment:

Drug: lasofoxifene

raloxifene

Active Comparator group

Description:

raloxifene 60 mg/day

Treatment:

Drug: raloxifene

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo