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lasofoxifene

Phase 3

Osteoporosis | Small molecule | Endocrine |Ligand Pharmaceuticals Incorporated|Last Updated: Aug 15, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment9,593

FDA Designations

No designations recorded

Clinical trial landscape

lasofoxifene · 4 trials · 2 indications

Phase 3 2Phase 2 2
NCT00163137Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone LossOsteoporosis
COMPLETED540 Analytics
NCT00141323Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)Osteoporosis
COMPLETED8,556 Analytics
PHASE3COMPLETED
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
OsteoporosisUnlock trial analytics
PHASE3COMPLETED
Postmenopausal Evaluation and Risk-reduction With Lasofoxifene (PEARL)
OsteoporosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Spine BMD after 2 years
2 years

Lumbar Spine Bome Mineral Density

New morphometric vertebral fractures
3 years
New cases of breast cancer
5 years
New non-vertebral fractures
5 years
Change in bone mineral density of the lumbar spine.
2 years
Effects of lasofoxifene compared to placebo on Bone Mineral Density (BMD) changes at the spine and hip after 1 year of treatment
12 months

Percent change from baseline in lumbar spine BMD at Month 12

Secondary Endpoints

Hip BMD and LDL-C after 2 years, vaginal pH and Maturation Index after 1 year
Hip BMD= 24 months, LDL-C= 24 months, vaginal pH= 24 months, vaginal epithelial parabasel cells= 12 months
All clinical fractures, non-vertebral fractures, BMD, breast cancer, cardiovascular events, and gynecological safety events
3 years
All clinical fractures, new morphometric vertebral fractures, BMD, cardiovascular events, and gynecological safety events
5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Lasofoxifene 0.25 mgEXPERIMENTALlasofoxifene 0.25 mg/day
raloxifeneACTIVE_COMPARATORraloxifene 60 mg/day
PlaceboPLACEBO_COMPARATORPlacebo
lasofoxifene 0.5 mg/dayEXPERIMENTAL -
lasofoxifene 0.25 mg/dayEXPERIMENTAL -
Lasofoxifene 0.25 mg/dEXPERIMENTAL -
Lasofoxifene Dose 1EXPERIMENTAL0.05 mg
Lasofoxifene Dose 2EXPERIMENTAL0.25 mg
Lasofoxifene Dose 3EXPERIMENTAL0.5 mg

Interventions

NameTypeDescription
lasofoxifeneDRUGlasofoxifene 0.25mg
raloxifeneDRUGraloxifene 60 mg/day
PlaceboDRUG0 mg/day
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Eligibility Criteria

Age Range48 Years to 75 Years
SexFEMALE
Healthy VolunteersYes
Study Sites72

Inclusion Criteria: * Postmenopausal women with low bone density (osteopenia) and screening labs, pelvic ultrasound, mammogram without significant findings Exclusion Criteria: * Presence of metabolic bone disease, fractures, blood clots, or recent cancer. * Any use of selective estrogen receptor ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaCosta RicaCroatiaDenmarkEgyptEstoniaFinlandFranceGermanyHong KongHungaryIndiaIrelandItalyJapanLithuaniaMexicoNorwayPolandRomaniaRussiaSouth AfricaSouth KoreaSpainSwedenTurkey (Türkiye)United KingdomTaiwan
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Competitive Landscape -Osteoporosis 8 trials

Frequently asked questions about lasofoxifene

What is Lasofoxifene used for?

Lasofoxifene is an investigational small molecule being developed for osteoporosis and bone loss in postmenopausal women. It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being studied for its effects on bone density and fracture risk reduction.

Who makes Lasofoxifene?

Lasofoxifene is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol LGND. The company is conducting clinical trials to evaluate the drug's safety and efficacy in postmenopausal women with osteoporosis and bone loss.

What phase is Lasofoxifene in?

Lasofoxifene is currently in Phase 2 clinical development. While some completed trials were Phase 3, the drug's overall development status is Phase 2, meaning it is still investigational and not yet approved for commercial use. All three completed trials have finished, with no active trials currently ongoing.

What clinical trials is Lasofoxifene in?

Lasofoxifene has been studied in three completed clinical trials. The largest, NCT00141323, was a Phase 3 study in 8,556 postmenopausal women with osteoporosis. NCT00143273 was a Phase 2 dose-response study in 497 Japanese and Asian women. NCT00163137 compared lasofoxifene to raloxifene and placebo in 540 women.

Is Lasofoxifene the same as raloxifene?

No, Lasofoxifene is not the same as raloxifene, though both are selective estrogen receptor modulators studied for osteoporosis. A completed Phase 3 trial (NCT00163137) directly compared lasofoxifene, raloxifene, and placebo on bone loss in postmenopausal women, indicating they are distinct drugs being evaluated for similar use.