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OpenTrials
Completed

NCT Number: NCT00088010

Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Age range

60 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary 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, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

arzoxifene

Drug

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

Other names: LY353381

Placebo

Drug

oral, tablet, once a day for 36 months

Primary outcomes

  1. Effects of arzoxifene on bone fractures and bone mass

    Time frame: 5 years

  2. Effects of arzoxifene on getting breast cancer

    Time frame: 5 years

  3. The safety of arzoxifene and any side effects

    Time frame: 5 years

Secondary outcomes

  1. Effects of arzoxifene on certain types of cardiovascular events

    Time frame: 5 years

  2. Effects of arzoxifene that changes the amount of certain substances in the blood that are related to osteoporosis and cardiovascular health

    Time frame: 5 years

  3. Effects of arzoxifene on the uterus

    Time frame: 5 years

  4. Effects of arzoxifene on cognition

    Time frame: 5 years

  5. Effects of arzoxifene on back pain

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jul 20, 2004
Registry last updated
Jun 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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