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Arzoxifene

Phase 3

Osteoporosis, Postmenopausal | Small molecule | Endocrine |Eli Lilly and Company|Last Updated: Apr 30, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment9,689

FDA Designations

No designations recorded

Clinical trial landscape

Arzoxifene · 6 trials · 6 indications

Phase 3 3Phase 2 3
NCT00383422Study Comparing Arzoxifene With Raloxifene in Women After Menopause With OsteoporosisOsteoporosis, Postmenopausal
COMPLETED320 Analytics
NCT00088010Effects of Arzoxifene on Bone Fractures and Incidence of Breast CancerOsteoporosis, Postmenopausal
COMPLETED9,369 Analytics
NCT00085956Effects of Arzoxifene on Bone Mass and the UterusPostmenopausal Bone Loss
COMPLETED300 Analytics
PHASE3COMPLETED
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
Effects of Arzoxifene on Bone Mass and the Uterus
Postmenopausal Bone LossUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in Lumbar Spine BMD
baseline to 12 months
Effects of arzoxifene on bone fractures and bone mass
5 years
Effects of arzoxifene on getting breast cancer
5 years
The safety of arzoxifene and any side effects
5 years
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
6 months

Secondary Endpoints

Secondary BMD measures of total hip and femoral neck
at 6 and 12 months
Biochemical markers of bone metabolism assessed
baseline, 3, 6, and 12 months
Assessment of coagulation parameters
baseline, 3, 6, and 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ArzoxifeneDRUG20 mg, oral, tablet, once a day for 52 weeks
RaloxifeneDRUG60 mg, oral, tablet, once a day for 52 weeks
PlaceboDRUGoral, tablet, once a day for 36 months
arzoxifene hydrochlorideDRUG -
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Eligibility Criteria

Age Range50 Years to 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Must have osteoporosis * Must be between 50 and 75 years old and be able to walk * Have at least two of your back bones that can be x-rayed * Have not had a period in at least two years * Be willing to have blood tests Exclusion Criteria: * Have a bone disease other than ost...

Countries:United StatesArgentinaAustraliaCanadaFranceItalySpainTaiwanSouth Korea
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Frequently asked questions about Arzoxifene

What is Arzoxifene used for?

Arzoxifene is an investigational small molecule being studied for postmenopausal osteoporosis, postmenopausal bone loss, ovarian cancer, and endometrial cancer. It is developed by Eli Lilly and Company (LLY). The drug has been evaluated in clinical trials, but it is not approved and remains in clinical development.

What does Arzoxifene target?

Arzoxifene is a selective estrogen receptor modulator (SERM) that targets estrogen receptors. It is being studied for its effects on bone mass and the uterus in postmenopausal women, as well as for hormone therapy in endometrial and ovarian cancers.

Who makes Arzoxifene?

Arzoxifene is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug has been studied in clinical trials for osteoporosis, postmenopausal bone loss, ovarian cancer, and endometrial cancer.

What phase is Arzoxifene in?

Arzoxifene has completed Phase 2 and Phase 3 clinical trials. It is not FDA approved and remains an investigational drug. The most advanced trial was a Phase 3 study of its effects on bone mass and the uterus in postmenopausal bone loss.

What clinical trials is Arzoxifene in?

Arzoxifene has been studied in four completed trials. NCT00085956 was a Phase 3 study of bone mass and the uterus in postmenopausal bone loss. NCT00767299 was a Phase 2 study in Korean women with osteoporosis. NCT00003669 and NCT00003670 were Phase 2 studies in endometrial and ovarian cancer.

Is Arzoxifene the same as Arzoxifene Hydrochloride?

Arzoxifene is the active drug, and Arzoxifene Hydrochloride is the salt form used in clinical trials. The trials NCT00003669 and NCT00003670 evaluated Arzoxifene Hydrochloride in endometrial and ovarian cancer, while other studies used Arzoxifene.