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

Thank you

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