BisCK

Botnar

Patients with chronic kidney impairment suffer from bone fragility. Yet, most fracture protective therapies are contraindicated for them due to uncertainty on specific safety issues. We will use anonymised electronic medical records data from patients who have used first line anti-osteoporosis treatments (i.e. The so called bisphosphonates) to explore their potential benefits (fracture risk reduction) and risks.

Risks and Benefits of bisphosphanate use in patients with chronic kidney disease

BACKGROUND

Patients with renal impairment have an increased risk of fractures. However, the most commonly used drugs to prevent these could have serious side effects for them. We will use data from thousands of patients with CKD who have been previously exposed to bisphosphonates to determine whether these medications are both safe and effective for them. - Daniel Prieto-Alhambra, Principal Investigator

With the aging population a growing number of patients are living with kidney disease. Kidney disease is associated with a significantly increased risk of broken bones (fractures) with substantial implications for patients, NHS and society. Although there are effective drugs such as bisphosphonates that reduce the risk of fracture in patients with osteoporosis (brittle bones), these drugs are untested in patients with kidney disease where the biology of the bone disease leading to bone fragility can be different. In addition some data suggests that these first-line bone therapies may worsen kidney function. Indeed, patients with kidney disease were under-represented or excluded from most randomised clinical trials, leaving a gap in the current medical knowledge about the potential benefits and risks of these medications in this growing group of the population. This evidence gap has led some to use untested treatment regimens in an attempt to reduce the risk of fracture.

OBJECTIVES

To address this, we propose to use ‘real life’ data as routinely collected in NHS clinical practice including primary and hospital care anonymised records for millions of UK people (the called CPRD/HES database), linked to the UK Renal Registry data, with detailed information on end-stage kidney disease. Finally, a unique Danish dataset including all patients who had a bone density scan in 1995-2013 will be used to study the effect of bisphosphonates on bone density in patients with kidney disease.

Data sources and Fair Processing

Large datasets from the UK Renal Registry (UKRR) alongside data from the Clinical Practice Research Datalink (CPRD) and Hospital episode Statistics (HES) will be used during this study. This information is collected during the normal course of healthcare.

The NHS Digital will act as a third trusted party in the linkage of data from the CPRD and the UKRR. After identifying each patient and linking their data from the CPRD (obtained from GP practices) and the UKRR (from renal centres), all the personal identifiers – such as name, address, NHS number or date of birth - will be removed , so the researchers at the University of Oxford will not be able to identify individual patients. This information will be processed in the public interest for research purposes. Only researchers at the University of Oxford will use this data for the sole purpose of this study.

The data controllers – that is, the organisations that decide how the data are used and with what aim – are the University of Oxford and the CPRD. The dataset will be kept for 12 months, as this time will be necessary to carry out the necessary analysis and publish the results of the study.

Since patient identifiers are removed from the dataset we use at the University of Oxford, we are not able to identify individuals. This means we would not be able to check if your information is included in the data we received from the databases, and we would not be able to remove your details in case you wanted to opt out.

You are entitled to raise a complaint to the supervisory authority (ICO).

This study is to be based in part on data from the Clinical Practice Research Datalink (CPRD) obtained under licence from the UK Medicines and Healthcare products Regulatory Agency. The data is to be provided by patients and collected by the NHS as part of their care and support. For more information about how CPRD uses patient data, including how it is collected and how patients can opt out of anonymised information from health records being used in medical research, visit https://www.cprd.com/public/.