APPENDIX 2 – PATIENT INFORMATION LEAFLETS

Patient Information Leaflet

(group 1)

This study is a research project, which is being conducted here in St James’ Hospital and in the Dublin Dental University Hospital. This information leaflet explains the aim of the study and what taking part will involve. If you would like to take part you will need to sign a consent form but it is important first that you fully understand what the study involves. You are under no obligation to take part in this study. What is this study about?

Osteoporosis is the most common disease of the bones and believed to cause more than 9 million fractures a year worldwide. In Ireland it is estimated that over 300,000 over the age of 50 have osteoporosis and as we have an ageing population this number is likely to increase. Osteoporosis related fragility fractures are one of the leading causes of patients becoming bed ridden in recent years and in developed countries the lifetime risk of fracture of the wrist, hip or vertebrae is believed to be between 30 to 40%.

The most widely used method of assessing osteoporosis is a DXA scan, which is a form of X-ray. Ultrasound, which does not use ionizing radiation, can also be used to assess bone density however as the research on its use is quite limited it requires further investigation.

A recent study undertaken in the Dublin Dental Hospital and St James’s Hospital showed that an ultrasound scan of the lower jaw was able to detect differences between osteoporosis sufferers and healthy individuals.

In this study we would like to investigate whether more sites of the face (forehead and cheekbone) would also detect these differences.

What will taking part in this study involve for me?

You will first be asked to fill out a questionnaire, which asks questions related to your medical history and lifestyle. If we have your consent you will then have an

ultrasound scan taken of your lower jaw, arm, leg, forehead and cheekbone. What are risks of taking part in this study?

Ultrasound is completely safe. There are no risks associated with this study. Who will be included in this study?

This study will concentrate on Caucasian females over the age of 18 years. Will my details be kept confidential?

Yes. Any data collected will not be associated with your name and your name will not be published.

Can I withdraw from the study?

You will be free to withdraw from the study at any stage.

Will you provide details of the information gathered during this study to my medical practitioner?

Patient Information Leaflet (group 2)

This study is a research project, which is being conducted here in St James’ Hospital and in the Dublin Dental University Hospital. This information leaflet explains the aim of the study and what taking part will involve. If you would like to take part you will need to sign a consent form but it is important first that you fully understand what the study involves. You are under no obligation to take part in this study and declining to take part will not affect your treatment here in any way.

What is this study about?

Osteoporosis is the most common disease of the bones and believed to cause more than 9 million fractures a year worldwide. In Ireland it is estimated that over 300,000 over the age of 50 have osteoporosis and as we have an ageing population this number is likely to increase. Osteoporosis related fragility fractures are one of the leading causes of elderly patients becoming bed ridden in recent years. In developed countries the lifetime risk of fracture of the wrist, hip or vertebrae is believed to be between 30 to 40%. Early diagnosis is very important.

The most widely used method of assessing osteoporosis is a DXA scan, which is a form of X-ray. Ultrasound, which does not use ionizing radiation, can also be used to assess bone density however as the research on its use is quite limited it requires further investigation.

This study is trying to determine if ultrasound of the lower jaw, forehead and cheekbone can be used to assess changes in the strength of bone in patients receiving treatment for osteoporosis over the course of one year. In this study, ultrasound readings will be taken from the lower jaw, forehead, cheekbone, leg and arm. These readings will be repeated after one year. These readings will be analyzed to determine if there are any changes over one year. These ultrasound readings will also be compared with DXA scans, calcaneal scans, and blood tests that you have as part of your osteoporosis assessment.

What will taking part in this study involve for me?

You will first be asked to fill out a questionnaire, which asks questions related to your medical history and lifestyle. You will then have an ultrasound scan taken of your lower jaw, arm, leg, forehead and cheekbone. In the Osteoporosis Clinic in St James’s Hospital it is routine to take DXA scans, calcaneal scans and blood tests to assess and monitor patients’ osteoporosis status.

If we have your consent, we will perform these tests with the ultrasound scans at the beginning of the study and repeat them after one year.

Will taking part in this study affect my medical treatment?

No. Taking part in this study will not affect your medical treatment in any way. What are risks of taking part in this study?

Ultrasound is completely safe. There is radiation associated with a DXA scan, as it is a form of x-ray, however this dose is very low and uses much less radiation than a standard x-ray. DXA scan is used as routine monitoring of your osteoporosis status in the osteoporosis clinic in St James’s Hospital.

Who will be included in this study?

This study will concentrate on Caucasian females only because the risk of

osteoporosis is unfortunately much higher in this group. You can only take part in this study if you are a Caucasian female and are a patient of the Osteoporosis Clinic in St James’s Hospital.

Will my details be kept confidential?

Yes. Any data collected will not be associated with your name and your name will not be published.

Can I withdraw from the study?

You will be free to withdraw from the study at any stage, including in the middle of treatment. This will not affect your treatment in any way.

Will you provide details of the information gathered during this study to my medical practitioner?