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


Phase 3
60 Years
85 Years
Not Enrolling
Female
Osteoporosis, Postmenopausal

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Effects of arzoxifene on bone fractures and bone mass

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

8536

NCT ID:

NCT00088010

Start Date:

June 2004

Completion Date:

November 2009

Related Keywords:

  • Osteoporosis, Postmenopausal
  • Breast Neoplasms
  • Osteoporosis
  • Osteoporosis, Postmenopausal

Name

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.Elk Grove, Illinois  60007