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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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)
Scientific title
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
Secondary ID [1] 0 0
A2181002
Universal Trial Number (UTN)
Trial acronym
PEARL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
New morphometric vertebral fractures
Timepoint [1] 0 0
3 years
Primary outcome [2] 0 0
New cases of breast cancer
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
New non-vertebral fractures
Timepoint [3] 0 0
5 years
Secondary outcome [1] 0 0
All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
Timepoint [2] 0 0
5 years

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.
Minimum age
60 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2007
Sample size
Target
8556
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Concord
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Ashford
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Dulwich
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Geelong
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5006 - Adelaide
Recruitment postcode(s) [4] 0 0
5035 - Ashford
Recruitment postcode(s) [5] 0 0
5065 - Dulwich
Recruitment postcode(s) [6] 0 0
3220 - Geelong
Recruitment postcode(s) [7] 0 0
3081 - Heidelberg
Recruitment postcode(s) [8] 0 0
WA 6009 - Nedlands
Recruitment postcode(s) [9] 0 0
NSW 2031 - Randwick
Recruitment outside Australia
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United States of America
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Alabama
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California
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Nebraska
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Virginia
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Argentina
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Buenos Aires
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Santa Fe
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Genk
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Cartago
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Iasi
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Sweden
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Goteborg
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Ankara
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Izmir
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United Kingdom
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Middlesex
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Scotland
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United Kingdom
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Northwood, Middlesex

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ligand Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00141323
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00141323