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Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL) (PEARL)

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
lasofoxifene
placebo
lasofoxifene
Sponsored by
Ligand Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

lasofoxifene 0.5 mg/day

placebo

lasofoxifene 0.25 mg/day

Arm Description

Outcomes

Primary Outcome Measures

New morphometric vertebral fractures
New cases of breast cancer
New non-vertebral fractures

Secondary Outcome Measures

All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events

Full Information

First Posted
August 30, 2005
Last Updated
August 8, 2011
Sponsor
Ligand Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00141323
Brief Title
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
Acronym
PEARL
Official Title
PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ligand Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8556 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lasofoxifene 0.5 mg/day
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
lasofoxifene 0.25 mg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
lasofoxifene
Intervention Description
0.5 mg once per day, orally
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Intervention Type
Drug
Intervention Name(s)
lasofoxifene
Intervention Description
0.25 mg once per day, orally
Primary Outcome Measure Information:
Title
New morphometric vertebral fractures
Time Frame
3 years
Title
New cases of breast cancer
Time Frame
5 years
Title
New non-vertebral fractures
Time Frame
5 years
Secondary Outcome Measure Information:
Title
All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
Time Frame
3 years
Title
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0659
Country
United States
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Pfizer Investigational Site
City
Palm Springs
State/Province
California
ZIP/Postal Code
92263
Country
United States
Facility Name
Pfizer Investigational Site
City
Poway
State/Province
California
ZIP/Postal Code
94064
Country
United States
Facility Name
Pfizer Investigational Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Pfizer Investigational Site
City
Brandon
State/Province
Florida
ZIP/Postal Code
33611
Country
United States
Facility Name
Pfizer Investigational Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Plaines
State/Province
Illinois
ZIP/Postal Code
60016
Country
United States
Facility Name
Pfizer Investigational Site
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Pfizer Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Pfizer Investigational Site
City
Montgomery Village
State/Province
Maryland
ZIP/Postal Code
20886
Country
United States
Facility Name
Pfizer Investigational Site
City
Arden Hills
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415-1226
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Pfizer Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Pfizer Investigational Site
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Pfizer Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleroia
State/Province
Pennsylvania
ZIP/Postal Code
15022
Country
United States
Facility Name
Pfizer Investigational Site
City
Monessen
State/Province
Pennsylvania
ZIP/Postal Code
15062
Country
United States
Facility Name
Pfizer Investigational Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Pfizer Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23227
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Pfizer Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Pfizer Investigational Site
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101-1448
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-4631
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Pfizer Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Pfizer Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1114AAH
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1117ABH
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
State/Province
Capital Federal
ZIP/Postal Code
C1287ACF
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000 DHL
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DHL
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Capital Federal - Buenos Aires
ZIP/Postal Code
C1012AAP
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Capital Federal
ZIP/Postal Code
C1115AAJ
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Capital Federal
ZIP/Postal Code
C1428AQK
Country
Argentina
Facility Name
Pfizer Investigational Site
City
S2000DHL- Rosario - Santa Fe
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Concord
State/Province
New South Wales
ZIP/Postal Code
NSW 2139
Country
Australia
Facility Name
Pfizer Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Pfizer Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Pfizer Investigational Site
City
Dulwich
State/Province
South Australia
ZIP/Postal Code
5065
Country
Australia
Facility Name
Pfizer Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Pfizer Investigational Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
WA 6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Randwick
ZIP/Postal Code
NSW 2031
Country
Australia
Facility Name
Pfizer Investigational Site
City
Genk
ZIP/Postal Code
3590
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04013002
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04062-003
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04230-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Caetano do Sul
State/Province
SP
ZIP/Postal Code
09540-830
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3X8
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H5B 1B2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Curridabat
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Paseo Colon
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Pedro
State/Province
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Cartago
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Escazu
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Zagreb
ZIP/Postal Code
10.000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Cairo
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Heliopolis, Cairo
Country
Egypt
Facility Name
Pfizer Investigational Site
City
Parnu
ZIP/Postal Code
80010
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallin
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallin
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
50410
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
FIN-00100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
FIN-90100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80809
Country
Germany
Facility Name
Pfizer Investigational Site
City
Shatin
State/Province
New Territories
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
New Territories
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1082
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
H-1088
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyor
ZIP/Postal Code
H-9023
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 033
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560-054
Country
India
Facility Name
Pfizer Investigational Site
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695 011
Country
India
Facility Name
Pfizer Investigational Site
City
Matunga (East)
State/Province
Mumbai
Country
India
Facility Name
Pfizer Investigational Site
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302017
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 014
Country
India
Facility Name
Pfizer Investigational Site
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 035
Country
India
Facility Name
Pfizer Investigational Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Facility Name
Pfizer Investigational Site
City
Jaipur
ZIP/Postal Code
302017
Country
India
Facility Name
Pfizer Investigational Site
City
New Delhi
ZIP/Postal Code
110 029
Country
India
Facility Name
Pfizer Investigational Site
City
Parel, Mumbai
ZIP/Postal Code
400 012
Country
India
Facility Name
Pfizer Investigational Site
City
Dublin
ZIP/Postal Code
2
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Verona
ZIP/Postal Code
37034
Country
Italy
Facility Name
Pfizer Investigational Site
City
Verona
ZIP/Postal Code
37122
Country
Italy
Facility Name
Pfizer Investigational Site
City
15-3-1 Maki Ohita-shi
State/Province
Ohita-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
2-7-8 Yoyogi Shibuya-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ohita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
100-380
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-3007
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-92288
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-01102
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-10318
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-2055
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-2600
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Mexico
State/Province
DF
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Tlalpan
State/Province
Mexico City
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Cp 11800
State/Province
Mexico Df
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Bergen
ZIP/Postal Code
5012
Country
Norway
Facility Name
Pfizer Investigational Site
City
Hamar
ZIP/Postal Code
2300
Country
Norway
Facility Name
Pfizer Investigational Site
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Pfizer Investigational Site
City
Hamar
ZIP/Postal Code
2318
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0164
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
0176
Country
Norway
Facility Name
Pfizer Investigational Site
City
Paradis
ZIP/Postal Code
5231
Country
Norway
Facility Name
Pfizer Investigational Site
City
Nowogrodzka 62A
State/Province
Warszawa
ZIP/Postal Code
02-002
Country
Poland
Facility Name
Pfizer Investigational Site
City
Krakow
ZIP/Postal Code
30-315
Country
Poland
Facility Name
Pfizer Investigational Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Pfizer Investigational Site
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
00-719
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
02-380
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warsaw
ZIP/Postal Code
02-634
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-341
Country
Poland
Facility Name
Pfizer Investigational Site
City
Timisoara
State/Province
Timis
ZIP/Postal Code
1900
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucharest
ZIP/Postal Code
70231
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucharest
Country
Romania
Facility Name
Pfizer Investigational Site
City
Bucuresti
ZIP/Postal Code
762511
Country
Romania
Facility Name
Pfizer Investigational Site
City
Iasi
ZIP/Postal Code
6600
Country
Romania
Facility Name
Pfizer Investigational Site
City
Timisoara
Country
Romania
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
101953
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
117815
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
190008
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7129
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
411 32
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3RX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Stanmore
State/Province
Middlesex
ZIP/Postal Code
HA7 4LP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 1LD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Northwood, Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20937977
Citation
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.
Results Reference
derived
PubMed Identifier
20181970
Citation
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].
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2181002&StudyName=Postmenopausal%20Evaluation%20and%20Risk-reduction%20with%20Lasofoxifene%20%28PEARL%29
Description
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Learn more about this trial

Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

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