Authors' objectives: 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. 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. As this is an observational study and the data have already been routinely collected whenever a patient is seen in any NHS facility, patients will not need to be randomized to receive bisphosphonates or any other treatment including water pills (placebo). Therefore, this approach will avoid exposing patients with kidney function impairment to unnecessary risks such as bisphosphonate-related potential adverse events. Advanced statistical methods will be used to match users of bisphosphonates to non-users with similar characteristics in order to provide a fair comparison. The current study will offer relevant information on the risks (side effects and renal disease progression/worsening) and potential benefits (fracture prevention) of the most commonly used treatment for osteoporosis (bisphosphonates) in UK patients with kidney impairment. Importantly, by using routinely collected data we will be able to make sure the study fully represents the general population of patients. This will make our final report a key piece of information for clinicians and patients with kidney impairment considering bisphosphonate therapy across the NHS. The proposed research group has extensive expertise in the analysis and interpretation of CPRD and UK Renal Registry data. Patient representatives have been involved in the design of this study, and will be part of steering group meetings to monitor the smooth progress of this research, which should be finished in a total period of 2 years time.

Project Status: Ongoing

URL for project: http://www.nets.nihr.ac.uk/projects/hta/143602

Anticipated Publish Date: 2021

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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