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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Sarah
Hardcastle
sarah.hardcastle@bristol.ac.uk
Dr
Celia
Gregson
celia.gregson@bristol.ac.uk
Dr
Jon
Tobias
jon.tobias@bristol.ac.uk
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Osteoporosis is a common condition which leads to significant morbidity and mortality from fractures. Several treatments for osteoporosis are licensed in the UK, including oral medications and injectable treatments. Some treatments work by preventing bone loss (antiresorptive treatments, such as intravenous zoledronate or subcutaneous denosumab) and others by increasing new bone formation (anabolic treatments, such as subcutaneous teriparatide).
Obesity is also very common in the general population and leads to a number of adverse health outcomes. There is increasing research interest in the relationship between bone and fat in both humans and animal models. Bone specific hormones such as osteocalcin have been shown to alter insulin sensitivity and fat deposition in animals, and other studies have suggested that these relationships also exist in man. Specifically, reduced levels of osteocalcin (seen when bone turnover is reduced) have been associated with increased fat mass and insulin resistance, suggesting an adverse effect on fat metabolism.
This study aims to investigate whether 3 different injectable treatments currently being used for osteoporosis (zoledronate, denosumab and teriparatide) have an effect on fat metabolism in patients. To achieve this we aim to recruit patients routinely commencing these treatments as part of usual clinical care, and assess changes in their metabolism before and after treatment. The assessments will include basic measurements such as height, weight and waist / hip circumference, blood tests to measure insulin and glucose and fats, and a DXA scan (similar to that routinely used to measure bone density) to measure total body fat. Patients will be followed up for 1 year after starting treatment; assessments will take place at baseline, 6 and 12 months. We hypothesize that we will see increases in body fat, glucose and insulin levels in patients taking antiresorptive treatments for osteoporosis, and vice versa.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Patients who have previously received either intravenous zoledronate, subcutaneous teriparatide or subcutaneous denosumab. Patients with pre-existing diabetes mellitus (type I) will also be excluded, as will patients who are pregnant or unable to provide written informed consent to participate.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Jon
Tobias
jon.tobias@bristol.ac.uk
Dr
Sarah
Hardcastle
sarah.hardcastle@bristol.ac.uk
Dr
Celia
Gregson
celia.gregson@bristol.ac.uk
The study is sponsored by NORTH BRISTOL NHS TRUST and funded by Medical Research Council (MRC) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 14036
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
