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Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

NCT00141323 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8556

Last updated 2011-08-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

lasofoxifene

0.5 mg once per day, orally

OTHER

placebo

placebo

DRUG

lasofoxifene

0.25 mg once per day, orally

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Costa Rica
  • Croatia
  • Denmark
  • Egypt
  • Estonia
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Norway
  • Poland
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00141323 on ClinicalTrials.gov