Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

Ligand Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Other: placebo; Drug: lasofoxifene

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141323

A2181002

Details and patient eligibility

About

The purpose of the study is to determine the safety and effectiveness of 2 doses of the investigational drug, lasofoxifene, compared to placebo (an inactive substance) in reducing new spinal fractures in women with osteoporosis.

Enrollment: 8,556 estimated patients

Sex: Female

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Postmenopausal at least 5 years; Screening bone mineral density more than or equal to 2.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Exclusion criteria

Metabolic bone disease other than osteoporosis; Taking approved medications for osteoporosis; Have had a recent osteoporotic fracture (within 1 year) and/or have a bone mineral density more than 4.5 S.D.s below the mean for young adults at the lumbar spine or femoral neck.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,556 participants in 3 patient groups, including a placebo group

lasofoxifene 0.5 mg/day

Experimental group

Treatment:

Drug: lasofoxifene

Drug: lasofoxifene

placebo

Placebo Comparator group

Treatment:

Other: placebo

lasofoxifene 0.25 mg/day

Experimental group

Treatment:

Drug: lasofoxifene

Drug: lasofoxifene