Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

Effects of Arzoxifene on Vertebral Fracture Incidence and on Invasive Breast Cancer Incidence in Postmenopausal Women With Osteoporosis or With Low Bone Density.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00088010

Enrollment

9369

Registered

2004-07-20

Start date

2004-06-30

Completion date

2009-11-30

Last updated

2010-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Postmenopausal

Brief summary

The purpose of this trial is to study: * Effects of arzoxifene on bone fractures and bone mass. * Effects of arzoxifene on getting breast cancer. * Effects of arzoxifene on certain types of cardiovascular events, such as heart attack and stroke. * Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health. * Effects of arzoxifene on the uterus. * The safety of arzoxifene and any side effects.

Interventions

DRUGArzoxifene

20mg, oral, tablet, once a day for 36 months

DRUGPlacebo

oral, tablet, once a day for 36 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

60 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 60-85 years of age * Female * At least two years since last menstrual cycle

Exclusion criteria

* Abnormal or unexplained vaginal bleeding. * Bone disorders, other than osteoporosis or low bone mass * History of breast cancer, cancer of the uterus, or any cancer in the last five years (except skin cancer). * History of cerebral vascular accidents or venous thromboembolic events * Medications outlined

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
Effects of arzoxifene on certain types of cardiovascular events	5 years
Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health	5 years
Effects of arzoxifene on the uterus	5 years
Effects of arzoxifene on cognition	5 years
Effects of arzoxifene on back pain	5 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026