Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

Ligand Pharmaceuticals8,556 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

8,556

Conditions

Osteoporosis

Interventions

lasofoxifeneDRUG

0.5 mg once per day, orally

placeboOTHER

placebo

lasofoxifeneDRUG

0.25 mg once per day, orally

Eligibility

Sex: FEMALEMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (201)

Outcomes

Primary Outcomes

New morphometric vertebral fractures

Time frame: 3 years

New cases of breast cancer

Time frame: 5 years

New non-vertebral fractures

Time frame: 5 years

Secondary Outcomes

All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events

Time frame: 3 years

All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events

Time frame: 5 years

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Birmingham, Alabama, United States

Pfizer Investigational Site

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Pfizer Investigational Site

La Jolla, California, United States

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...and 191 more locations