In addition to determining whether denosumab can help decrease the risk of breast cancer, researchers are looking at other ways that denosumab can affect a woman’s health and well-being.
There are 3 optional sub-studies available to study participants. Your study doctor will offer them if you are eligible, but you can also ask to participate if you are interested.
Note: Taking part in these optional sub-studies is your choice. You can still take part in the main study even if you say no to any or all the optional sub-studies. There is no penalty for saying no. If you sign up for an optional sub-study but cannot complete it for any reason, you can still take part in the main study.
If you decide to join the bone sub-study, you will have a bone scan, called a “high-resolution peripheral quantitative computed tomography” (HR-pQCT) scan. This scan uses special scanners and computers to measure the density of the bones in your arms and legs. These scans provide more detailed X-ray images than a standard bone density test. Right now, this scan is used for research only, however, the results will be shared with you. Researchers will use this scan to learn more about how denosumab affects bone health. There is no charge for this extra bone scan.
Note: Currently, this study is only offered to study participants at some sites due to limited scanner availability.
What participation involves: During the HR-pQCT scan, you will be asked to sit in a chair and rest your arm or foot in the scanner. You will be asked to hold still for 2 to 3 minutes during each scan.
The HR-pQCT scan uses a very small amount of radiation to do its measurements. The total amount of radiation exposure would be the same as what you would normally get from natural background sources in the earth and the sky in less than 1 month.
If you choose to take part in this study, you will be asked to fill out questionnaires about any symptoms or side effects you might have, as well as questions about your quality of life and your physical, mental, and social well-being. Researchers will use this information to better understand how you feel during treatment and to assess the effects of denosumab on your quality of life.
Since the questionnaires are being used for research, your responses will not be shared with your doctors.
What participation involves: You will be asked to fill out questionnaires on paper or online at the beginning of the study and then every 6 months for 5 years (11 times in total). These forms are currently only available in English.
Each form will take about 10 minutes to complete. You don’t have to answer any question that makes you feel uncomfortable.
For this sub-study, researchers are aiming to learn more about breast cancer and other health problems using blood and tissue samples from women who take part in clinical trials. By studying these samples, researchers hope to find new ways to prevent, detect, treat, and cure diseases like breast cancer.
What participation involves: If you choose to take part in this sub-study, researchers will collect blood and breast tissue (ONLY if you have a mastectomy or develop breast cancer during the study). Your blood and tissue donations will help researchers study new ways to test for cancer, how denosumab may affect the blood and breasts, and how it helps to prevent and/or reduce cancer risk.