OsteoporosisPhase 3PEARLNCT00141323

Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)

A Phase 3 study testing lasofoxifene in people with Osteoporosis, run by Ligand Pharmaceuticals at 201 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 60 to 80 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: lasofoxifene
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8,556 participants
Where: 201 sitesin 32 countries
Study dates: Nov 2001to Dec 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 80 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

201 sites in 32 countries.

Country

City, postcode or hospital

201 sites in 32 countries

United States48 sites

Pfizer Investigational Site
Albuquerque, New Mexico, 87102
Pfizer Investigational Site
Albuquerque, New Mexico, 87106
Pfizer Investigational Site
Arden Hills, Minnesota, 55112
Pfizer Investigational Site
Bethesda, Maryland, 20817
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35216
Pfizer Investigational Site
Brandon, Florida, 33611
Pfizer Investigational Site
Centerville, Ohio, 45459
Pfizer Investigational Site
Charleroia, Pennsylvania, 15022
Pfizer Investigational Site
Cordova, Tennessee, 38018
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dayton, Ohio, 45409
Pfizer Investigational Site
Des Moines, Iowa, 50309
Pfizer Investigational Site
Des Plaines, Illinois, 60016
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92093-0659
Pfizer Investigational Site
La Jolla, California, 92161
Pfizer Investigational Site
Leesburg, Florida, 34748
Pfizer Investigational Site
Memphis, Tennessee, 38119
Pfizer Investigational Site
Minneapolis, Minnesota, 55415-1226
Pfizer Investigational Site
Monessen, Pennsylvania, 15062
Pfizer Investigational Site
Montgomery Village, Maryland, 20886
Pfizer Investigational Site
Morton Grove, Illinois, 60053
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Palm Desert, California, 92260
Pfizer Investigational Site
Palm Springs, California, 92262
Pfizer Investigational Site
Palm Springs, California, 92263
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Poway, California, 94064
Pfizer Investigational Site
Rancho Mirage, California, 92270
Pfizer Investigational Site
Redmond, Washington, 98052
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Richmond, Virginia, 23227
Pfizer Investigational Site
Richmond, Virginia, 23229
Pfizer Investigational Site
Richmond, Virginia, 23235
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
San Diego, California, 92128
Pfizer Investigational Site
Seattle, Washington, 98101-1448
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Seattle, Washington, 98105-4631
Pfizer Investigational Site
Seattle, Washington, 98112
Pfizer Investigational Site
Seattle, Washington, 98133
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
Tampa, Florida, 33607
Pfizer Investigational Site
Tampa, Florida, 33613
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
West Palm Beach, Florida, 33414

Other trials in United States

Canada15 sites

Pfizer Investigational Site
Calgary, Alberta, T2N 2T9
Pfizer Investigational Site
Calgary, Alberta, T2N 4N1
Pfizer Investigational Site
Hamilton, Ontario, L8N 1Y2
Pfizer Investigational Site
Hamilton, Ontario, L8N 2B6
Pfizer Investigational Site
Hamilton, Ontario, L8N 4A6
Pfizer Investigational Site
Montreal, Quebec, H2X 1P1
Pfizer Investigational Site
Montreal, Quebec, H5B 1B2
Pfizer Investigational Site
Sainte-Foy, Quebec, G1V 3M7
Pfizer Investigational Site
Sainte-Foy, Quebec, G1V 4G2
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0H6
Pfizer Investigational Site
Toronto, Ontario, M5C 2T2
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 3A6
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 3Y1
Pfizer Investigational Site
Vancouver, British Columbia, V6H 3X8
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

India11 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560-054
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 014
Pfizer Investigational Site
Chennai, Tamil Nadu, 600 035
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Jaipur, Rajasthan, 302017
Pfizer Investigational Site
Jaipur, 302017
Pfizer Investigational Site
Matunga (East), Mumbai
Pfizer Investigational Site
New Delhi, 110 029
Pfizer Investigational Site
Parel, Mumbai, 400 012
Pfizer Investigational Site
Thiruvananthapuram, Kerala, 695 011
Pfizer Investigational Site
Vellore, Tamil Nadu, 632004

Other trials in India

Argentina9 sites

Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., C1287ACF
Pfizer Investigational Site
Capital Federal, Buenos Aires, C1114AAH
Pfizer Investigational Site
Capital Federal, Buenos Aires, C1117ABH
Pfizer Investigational Site
Capital Federal, C1115AAJ
Pfizer Investigational Site
Capital Federal, C1428AQK
Pfizer Investigational Site
Capital Federal - Buenos Aires, C1012AAP
Pfizer Investigational Site
Rosario, Santa Fe Province, S2000 DHL
Pfizer Investigational Site
Rosario, Santa Fe Province, S2000DHL
Pfizer Investigational Site
S2000dhl- Rosario - Santa Fe

Other trials in Argentina

Australia9 sites

Pfizer Investigational Site
Adelaide, South Australia, 5006
Pfizer Investigational Site
Ashford, South Australia, 5035
Pfizer Investigational Site
Concord, New South Wales, NSW 2139
Pfizer Investigational Site
Dulwich, South Australia, 5065
Pfizer Investigational Site
Geelong, Victoria, 3220
Pfizer Investigational Site
Heidelberg, Victoria, 3081
Pfizer Investigational Site
Nedlands, Western Australia, WA 6009
Pfizer Investigational Site
Randwick, New South Wales, 2031
Pfizer Investigational Site
Randwick, NSW 2031

Other trials in Australia

Poland8 sites

Pfizer Investigational Site
Krakow, 30-315
Pfizer Investigational Site
Krakow, 31-501
Pfizer Investigational Site
Nowogrodzka 62A, Warszawa, 02-002
Pfizer Investigational Site
Warsaw, 00-416
Pfizer Investigational Site
Warsaw, 00-719
Pfizer Investigational Site
Warsaw, 02-341
Pfizer Investigational Site
Warsaw, 02-380
Pfizer Investigational Site
Warsaw, 02-634

Other trials in Poland

Russia8 sites

Pfizer Investigational Site
Moscow, 101953
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Moscow, 117036
Pfizer Investigational Site
Moscow, 117815
Pfizer Investigational Site
Moscow
Pfizer Investigational Site
Saint Petersburg, 190008
Pfizer Investigational Site
Saint Petersburg, 199034

Other trials in Russia

United Kingdom8 sites

Pfizer Investigational Site
Aberdeen, Scotland, AB25 1LD
Pfizer Investigational Site
Aberdeen, Scotland, AB25 2ZD
Pfizer Investigational Site
Aberdeen, Scotland, AB25 2ZN
Pfizer Investigational Site
Harrow, Middlesex, HA1 3RX
Pfizer Investigational Site
Harrow, Middlesex, HA1 3UJ
Pfizer Investigational Site
Northwood, Middlesex, HA6 2RN
Pfizer Investigational Site
Northwood, Middlesex, HA6 2RN
Pfizer Investigational Site
Stanmore, Middlesex, HA7 4LP

Other trials in United Kingdom

Costa Rica7 sites

Pfizer Investigational Site
Cartago, Cartago Province
Pfizer Investigational Site
Curridabat, Provincia de San José
Pfizer Investigational Site
Escazú
Pfizer Investigational Site
Paseo Colon, Provincia de San José
Pfizer Investigational Site
San José, Provincia de San José
Pfizer Investigational Site
San José
Pfizer Investigational Site
San Pedro, Provincia de San José

Other trials in Costa Rica

Lithuania7 sites

Pfizer Investigational Site
Kaunas, LT-3007
Pfizer Investigational Site
Kaunas, LT-50009
Pfizer Investigational Site
Klaipėda, LT-92288
Pfizer Investigational Site
Vilnius, LT-01102
Pfizer Investigational Site
Vilnius, LT-10318
Pfizer Investigational Site
Vilnius, LT-2055
Pfizer Investigational Site
Vilnius, LT-2600

Other trials in Lithuania

Norway7 sites

Pfizer Investigational Site
Bergen, 5012
Pfizer Investigational Site
Hamar, 2300
Pfizer Investigational Site
Hamar, 2317
Pfizer Investigational Site
Hamar, 2318
Pfizer Investigational Site
Oslo, 0164
Pfizer Investigational Site
Oslo, 0176
Pfizer Investigational Site
Paradis, 5231

Other trials in Norway

Romania6 sites

Pfizer Investigational Site
Bucharest, 70231
Pfizer Investigational Site
Bucharest, 762511
Pfizer Investigational Site
Bucharest
Pfizer Investigational Site
Iași, 6600
Pfizer Investigational Site
Timișoara, Timiș County, 1900
Pfizer Investigational Site
Timișoara

Other trials in Romania

Estonia5 sites

Pfizer Investigational Site
Pärnu, 80010
Pfizer Investigational Site
Tallinn, 10138
Pfizer Investigational Site
Tallinn, 11312
Pfizer Investigational Site
Tallinn, 13419
Pfizer Investigational Site
Tartu, 50410

Other trials in Estonia

Hungary5 sites

Pfizer Investigational Site
Budapest, H-1082
Pfizer Investigational Site
Budapest, H-1088
Pfizer Investigational Site
Debrecen, H-4012
Pfizer Investigational Site
Győr, H-9023
Pfizer Investigational Site
Győr, H-9024

Other trials in Hungary

Japan5 sites

Pfizer Investigational Site
15-3-1 Maki Ohita-shi, Ohita-ken
Pfizer Investigational Site
2-7-8 Yoyogi Shibuya-ku, Tokyo
Pfizer Investigational Site
Ohita, Ohita
Pfizer Investigational Site
Shinjuku-ku, Tokyo
Pfizer Investigational Site
Tokyo

Other trials in Japan

Brazil4 sites

Pfizer Investigational Site
São Caetano do Sul, São Paulo, 09540-830
Pfizer Investigational Site
São Paulo, São Paulo, 04013002
Pfizer Investigational Site
São Paulo, São Paulo, 04062-003
Pfizer Investigational Site
São Paulo, São Paulo, 04230-000

Other trials in Brazil

Italy4 sites

Pfizer Investigational Site
Florence, 50134
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Verona, 37034
Pfizer Investigational Site
Verona, 37122

Other trials in Italy

South Africa4 sites

Pfizer Investigational Site
Bloemfontein, 9300
Pfizer Investigational Site
Cape Town, 7129
Pfizer Investigational Site
Cape Town, 7500
Pfizer Investigational Site
Johannesburg, 2196

Other trials in South Africa

Finland3 sites

Pfizer Investigational Site
Helsinki, FIN-00100
Pfizer Investigational Site
Oulu, FIN-90100
Pfizer Investigational Site
Turku, 20100

Other trials in Finland

France3 sites

Pfizer Investigational Site
Lyon, 69003
Pfizer Investigational Site
Lyon, 69437
Pfizer Investigational Site
Paris, 75674

Other trials in France

Germany3 sites

Pfizer Investigational Site
Berlin, 12200
Pfizer Investigational Site
Berlin, 12203
Pfizer Investigational Site
München, 80809

Other trials in Germany

Mexico3 sites

Pfizer Investigational Site
Cp 11800, Mexico Df
Pfizer Investigational Site
Mexico City, Mexico City, 14050
Pfizer Investigational Site
Tlalpan, Mexico City, 14000

Other trials in Mexico

Turkey (Türkiye)3 sites

Pfizer Investigational Site
Ankara, 06590
Pfizer Investigational Site
Izmir, 35100
Pfizer Investigational Site
Izmir

Other trials in Turkey (Türkiye)

Belgium2 sites

Pfizer Investigational Site
Genk, 3590
Pfizer Investigational Site
Leuven, 3000

Other trials in Belgium

Croatia2 sites

Pfizer Investigational Site
Zagreb, 10.000
Pfizer Investigational Site
Zagreb, 10000

Other trials in Croatia

Denmark2 sites

Pfizer Investigational Site
Aarhus C, 8000
Pfizer Investigational Site
Hvidovre, DK-2650

Other trials in Denmark

Egypt2 sites

Pfizer Investigational Site
Cairo
Pfizer Investigational Site
Heliopolis, Cairo

Other trials in Egypt

Hong Kong2 sites

Pfizer Investigational Site
New Territories, Hong Kong
Pfizer Investigational Site
Shatin, New Territories

Other trials in Hong Kong

Ireland2 sites

Pfizer Investigational Site
Dublin, Dublin, 2
Pfizer Investigational Site
Dublin, 2

Other trials in Ireland

Spain2 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
Madrid, Madrid, 28041

Other trials in Spain

South Korea1 site

Pfizer Investigational Site
Seoul, Korea, 100-380

Other trials in South Korea

Sweden1 site

Pfizer Investigational Site
Gothenburg, 411 32

Other trials in Sweden

About this study

Official title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene

Conditions: Osteoporosis
Being tested: lasofoxifene, placebo
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lasofoxifeneDrug
0.5 mg once per day, orally
placeboOther
placebo
lasofoxifeneDrug
0.25 mg once per day, orally

Study groups in NCT00141323
Study group	Role	What they receive
lasofoxifene 0.5 mg/day	Experimental	Not described Receives: Drug: lasofoxifene
placebo	Placebo comparator	Not described Receives: Other: placebo
lasofoxifene 0.25 mg/day	Experimental	Not described Receives: Drug: lasofoxifene

What is being measured

The primary outcome is the main question the study is designed to answer.

New morphometric vertebral fractures
Measured: 3 years
New cases of breast cancer
Measured: 5 years
New non-vertebral fractures
Measured: 5 years

Secondary outcomes (2)

All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
Measured: 3 years
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2001Dec 2007

First posted1 Sep 2005 (estimated)
Study startNov 2001
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8,556 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00141323
Sponsor's protocol ID: A2181002
Acronym: PEARL
Status last verified: Aug 2011
First submitted: 30 Aug 2005
Last updated: 15 Aug 2011
Results posted: No
Data monitoring committee: Yes

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.
PubMed 20937977
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.
PubMed 20181970

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis

All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PEARL: Postmenopausal Evaluation And Risk-Reduction With Lasofoxifene
ClinicalTrials.gov ID: NCT00141323
Acronym / sponsor ID: PEARL / A2181002
Conditions: Osteoporosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,556 participants (estimated)
Lead sponsor: Ligand PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Nov 2001
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 1 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
lasofoxifene 0.5 mg/day	Experimental	Drug: lasofoxifene
placebo	Placebo comparator	Other: placebo
lasofoxifene 0.25 mg/day	Experimental	Drug: lasofoxifene

Who may qualify

Ages: 60 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lasofoxifene0.5 mg once per day, orally	Drug	lasofoxifene 0.5 mg/day
placeboplacebo	Other	placebo
lasofoxifene0.25 mg once per day, orally	Drug	lasofoxifene 0.25 mg/day

Primary outcome

New morphometric vertebral fractures
Time frame: 3 years
New cases of breast cancer
Time frame: 5 years
New non-vertebral fractures
Time frame: 5 years

2 secondary outcomes

All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
Time frame: 3 years
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
Derived from this study: PubMed 20937977Ensrud 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.
Derived from this study: PubMed 20181970Cummings 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Osteoporosis

Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

201 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing lasofoxifene in people with Osteoporosis, run by Ligand Pharmaceuticals at 201 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 201 sites in United States, Canada, India, Argentina, Australia and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New morphometric vertebral fractures (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00141323, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.