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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00141323
Registration number
NCT00141323
Ethics application status
Date submitted
30/08/2005
Date registered
1/09/2005
Date last updated
15/08/2011
Titles & IDs
Public title
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
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Scientific title
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
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Secondary ID [1]
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0
A2181002
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Universal Trial Number (UTN)
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Trial acronym
PEARL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Osteoporosis
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Condition category
Condition code
Musculoskeletal
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0
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Osteoporosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - lasofoxifene
Other interventions - placebo
Treatment: Drugs - lasofoxifene
Experimental: lasofoxifene 0.5 mg/day -
Placebo comparator: placebo -
Experimental: lasofoxifene 0.25 mg/day -
Treatment: Drugs: lasofoxifene
0.5 mg once per day, orally
Other interventions: placebo
placebo
Treatment: Drugs: lasofoxifene
0.25 mg once per day, orally
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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0
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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New morphometric vertebral fractures
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Assessment method [1]
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Timepoint [1]
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3 years
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Primary outcome [2]
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New cases of breast cancer
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Assessment method [2]
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Timepoint [2]
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5 years
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Primary outcome [3]
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New non-vertebral fractures
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Assessment method [3]
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0
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Timepoint [3]
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5 years
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Secondary outcome [1]
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All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
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Assessment method [1]
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Timepoint [1]
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3 years
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Secondary outcome [2]
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All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
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Assessment method [2]
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Timepoint [2]
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5 years
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Eligibility
Key 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.
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Minimum age
60
Years
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Maximum age
80
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2007
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Sample size
Target
8556
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Concord
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Pfizer Investigational Site - Randwick
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Pfizer Investigational Site - Heidelberg
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Pfizer Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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NSW 2139 - Concord
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Recruitment postcode(s) [2]
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2031 - Randwick
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5006 - Adelaide
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5035 - Ashford
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5065 - Dulwich
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3220 - Geelong
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Recruitment postcode(s) [7]
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3081 - Heidelberg
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Recruitment postcode(s) [8]
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WA 6009 - Nedlands
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Recruitment postcode(s) [9]
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NSW 2031 - Randwick
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Recruitment outside Australia
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Northwood, Middlesex
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Ligand Pharmaceuticals
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Address
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Ethics approval
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT00141323
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Trial related presentations / publications
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. doi: 10.1161/CIRCULATIONAHA.109.924571. Epub 2010 Oct 11. 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. doi: 10.1056/NEJMoa0808692. Erratum In: N Engl J Med. 2011 Jan 20;364(3):290. Kucu kdeveci A [corrected to Kucukdeveci, A].
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00141323
Download to PDF