Clinical Trial 20456

Denton, TX 76210


Summary:

After menopause, women are at higher risk for bone loss. One of the major reasons is because estrogen, a hormone that is important for building and maintaining bone strength, declines with menopause. This bone loss can lead to osteoporosis, a condition of weakened bones that raises the risk of fracture. Postmenopausal osteoporosis can occur without any symptoms, and often goes undiagnosed until a bone is fractured or one or more vertebrae (bones in the spine) collapse.

If you are a woman who has gone through menopause and are between the ages of 60 and 90, you may qualify for one of two ongoing clinical research studies of an investigational medication for women with postmenopausal osteoporosis at increased risk for fracture. During the study, participants will need to visit a study doctor for medical exams and tests that are required for the study.

The study doctor will discuss these and other eligibility criteria with you and answer any questions you may have about the study. Study participation is voluntary.

What’s the purpose of the studies?
The purpose of these studies is to see if an investigational medication called romosozumab is safe and effective in the prevention of fractures in postmenopausal women.

Who can participate?
You may be eligible to participate if you:

  • Are a postmenopausal woman with osteoporosis
  • Are 55 to 90 years old

This is a partial list. Other eligibility criteria apply.

How long will each study last?
Each study lasts for approximately 2-3 years. The actual duration will depend on the study for which you qualify. The study site staff will discuss this with you.

What will happen during study participation?
You will be asked to visit the research center at regular intervals for study-required physical exams, blood tests, X-rays, bone density tests, and other study-related medical evaluations. You will not be charged for study-required procedures.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.