About Patient Forms

Real-World Long-Term Skeletal and Extra-Skeletal Outcomes of Obesity, Diabetes, Ageing, Frailty, and Sarcopenia: The Oswestry Metabolic BONE Cohort (OsBONE)

Why Are Researchers Doing This Study?

This research will aim to improve our understanding of how bone health is affected by lifestyle factors and general health. As one of the largest metabolic bone units in the UK, we have the opportunity to study the effect of a range of diseases and lifestyle factors and how these impact the risk of bone fracture(s). The ultimate aim of this research would be to learn how to treat different patients, with different diseases effectively and reduce their risk of broken bones.

Some of the diseases and lifestyle factors we are interested in studying will be; diabetes, body mass index (BMI), mobility, physical activity, muscle strength and function, sarcopenia (age related loss of muscle mass and strength), frailty, balance, pain and general health. For example, we believe that being very overweight, or obese, could increase the risk of a broken bone, also known as fracture. This is because previous research has shown that people who are obese have a higher risk of broken bones. However, because many of these patients have a high bone mineral density due to their increased weight, they are not eligible to receive drug therapy for osteoporosis (brittle weak bones) according to national treatment guidelines. Studying how certain health conditions and lifestyle factors affect the risk of broken bones may mean that more patients, who are currently ineligible for treatment, will be able to be treated in the future with anti-osteoporosis drugs that strengthen the bone and reduce the risk of further broken bones.

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Therefore, we will ask your consent to take part in all or some of the following research activities:

We would like to ask you some questions about your current health and lifestyle using a questionnaire. For this study, we need to recruit patients who have low, normal, or increased weight as well as patients with and without other diseases. We will then use this information along with some data from your medical history to look for relationships between health and disease status and increased fracture risk.

This depends on your medical history and why you have been referred to the metabolic bone clinic. Your clinical team will explain all tests that are needed as part of your standard of care. If any tests are needed for research, the type of research and involvement will be discussed with you by a member of the clinical or research team and you will be given the opportunity to ask questions. If you agree to taking part in research, you will be asked for your consent by way of signing a form. If you chose not to, that is absolutely fine and your NHS care will not be affected in any way. Some examples of extra research tests might include an extra blood test or a specialised scan.

These diagnostic tests will be done on a small group of patients. With your consent, we would like to perform a special type of X-ray scan called a QCT (Quantitative Computed Tomography) scan to look at the bones in your spine, hip, wrist, and/or lower leg (tibia). The QCT provides detailed images of bone structure that a regular bone density scan cannot. Bone structure is an important factor in bone strength and susceptibility to fracture. Additionally, we would like to perform an MRI scan of the muscles and bones in your spine and lower leg to assess muscle mass and detect changes in bone that can predict health problems such as diabetes and fractures.Whilst MRI scans do not expose your body to any extra radiation, the amount of radiation you will be exposed to during a QCT spine/hip is similar to what you naturally get from the environment over about 4-8 months. However, the radiation dose is actually much lower when measured at the wrist and lower leg.

The strength and performance of your muscles are very important for your skeletal health. To assess this scientifically, we may ask you to perform some simple tests during your visit to the clinic. These tests might include walking a short distance, standing up from a seated position in a chair and then sitting back down as quickly as possible. Additionally, we might ask you to stand on a special metal plate on the floor and perform one standing jump. It doesn’t matter if you can’t jump high or even if your feet do not leave the floor; this is all part of the test. The plate, called a mechanograph, will accurately measure your muscle power and function, and assess your balance. The mechanograph will measure various physical parameters and provide us with valuable information on muscle performance, balance, and body stiffness, helping us understand how these factors affect your bone health.

Whilst there is no immediate, direct benefit to you by taking part; by participating in this study, information will be collected to understand the factors that affect bone health and fracture risk. This will highlight areas to target resources of future research and treatment programmes on future patients, possibly having some bearing on influencing your care in the future. Participating in this research study is entirely up to you. Choosing not to take part will not influence your care in any way. Similarly, if you consent to participate and then change your mind, just let us know and you will not be contacted again regarding this study.

This is a single centre research study which is being sponsored by The Robert Jones and Agnes Hunt Orthopaedic Hospital (RJAH). You have been approached and invited to participate, based on you being deemed eligible to participate by one of your clinical care team. You have been sent or given this Information Sheet and Consent Form, to consider participating in this research study. By signing the Consent Form, you are agreeing to participate in this study and to be contacted further by us regarding the study. We may also contact you shortly after sending the information as a courtesy, to check the information has been received and to see if you have any questions. You will be able to sign the consent form at the hospital when you attend your clinic or bone density scan using an iPad with the assistance of the metabolic bone team if needed. There will also be a safe online website dedicated for the study where you can sign an electronic consent form and fill in questionnaires related to bone health and general health. This study will gather information by using questionnaires and information from your past medical history and any hospital admission.

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Whilst there is no immediate, direct benefit to you by taking part; by participating in this study, information will be collected to understand the factors that affect bone health and fracture risk. This will highlight areas to target resources of future research and treatment programmes on future patients, possibly having some bearing on influencing your care in the future. Participating in this research study is entirely up to you. Choosing not to take part will not influence your care in any way. Similarly, if you consent to participate and then change your mind, just let us know and you will not be contacted again regarding this study.

This is a single centre research study which is being sponsored by The Robert Jones and Agnes Hunt Orthopaedic Hospital (RJAH). You have been approached and invited to participate, based on you being deemed eligible to participate by one of your clinical care team. You have been sent or given this Information Sheet and Consent Form, to consider participating in this research study. By signing the Consent Form, you are agreeing to participate in this study and to be contacted further by us regarding the study. We may also contact you shortly after sending the information as a courtesy, to check the information has been received and to see if you have any questions. You will be able to sign the consent form at the hospital when you attend your clinic or bone density scan using an iPad with the assistance of the metabolic bone team if needed. There will also be a safe online website dedicated for the study where you can sign an electronic consent form and fill in questionnaires related to bone health and general health. This study will gather information by using questionnaires and information from your past medical history and any hospital admission.