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Completed

NCT Number: NCT00141323

Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Capital Federal, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lasofoxifene

Drug

0.5 mg once per day, orally

Placebo

Other

placebo

Primary outcomes

  1. New morphometric vertebral fractures

    Time frame: 3 years

  2. New cases of breast cancer

    Time frame: 5 years

  3. New non-vertebral fractures

    Time frame: 5 years

Secondary outcomes

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

    Time frame: 3 years

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

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Ligand Pharmaceuticals

Industry

Registry information

Official study title

PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

Acronym: PEARL

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 1, 2005
Registry last updated
Aug 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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