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NCT00088010 Clinical Trial

Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00088010
Other study ID # 8536
Secondary ID H4Z-MC-GJAD
Status Completed
Phase Phase 3
First received July 19, 2004
Last updated May 27, 2010
Start date June 2004
Est. completion date November 2009

Study information
Verified date May 2010
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9369
Est. completion date November 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Female
Age group 60 Years to 85 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Arzoxifene
20mg, oral, tablet, once a day for 36 months
• Placebo
oral, tablet, once a day for 36 months

Locations
Country Name City State
United States 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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effects of arzoxifene on bone fractures and bone mass 5 years No
Primary Effects of arzoxifene on getting breast cancer 5 years Yes
Primary The safety of arzoxifene and any side effects 5 years Yes
Secondary Effects of arzoxifene on certain types of cardiovascular events 5 years Yes
Secondary Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health 5 years Yes
Secondary Effects of arzoxifene on the uterus 5 years Yes
Secondary Effects of arzoxifene on cognition 5 years No
Secondary Effects of arzoxifene on back pain 5 years No
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