Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: lasofoxifene Other: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fractures Osteoporosis

U.S. FDA Resources

Further study details as provided by Ligand Pharmaceuticals:

Primary Outcome Measures:

New morphometric vertebral fractures [ Time Frame: 3 years ] [ Designated as safety issue: No ]
New cases of breast cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
New non-vertebral fractures [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	8556
Study Start Date:	November 2001
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: lasofoxifene 0.5 mg/day	Drug: lasofoxifene 0.5 mg once per day, orally
Placebo Comparator: placebo	Other: placebo placebo
Experimental: lasofoxifene 0.25 mg/day	Drug: lasofoxifene 0.25 mg once per day, orally

Eligibility

Ages Eligible for Study:	60 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141323

Show 202 Study Locations

Sponsors and Collaborators

Ligand Pharmaceuticals

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Ligand Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ensrud K, LaCroix A, Thompson JR, Thompson DD, Eastell R, Reid DM, Vukicevic S, Cauley J, Barrett-Connor E, Armstrong R, Welty F, Cummings S. Lasofoxifene and cardiovascular events in postmenopausal women with osteoporosis: Five-year results from the Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL) trial. Circulation. 2010 Oct 26;122(17):1716-24. Epub 2010 Oct 11.

Reginster JY. Interest of lasofoxifene in the treatment of osteoporosis. Evaluation of "Lasofoxifene in postmenopausal women with osteoporosis". N Engl J Med 2010;362:686-96. Expert Opin Pharmacother. 2010 Jul;11(10):1773-5.

Cummings SR, Ensrud K, Delmas PD, LaCroix AZ, Vukicevic S, Reid DM, Goldstein S, Sriram U, Lee A, Thompson J, Armstrong RA, Thompson DD, Powles T, Zanchetta J, Kendler D, Neven P, Eastell R; PEARL Study Investigators. Lasofoxifene in postmenopausal women with osteoporosis. N Engl J Med. 2010 Feb 25;362(8):686-96.

Responsible Party:	Director, Project Management, Ligand Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00141323 History of Changes
Other Study ID Numbers:	A2181002
Study First Received:	August 30, 2005
Last Updated:	August 8, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013