BisCK study
Research type
Research Study
Full title
Risks and benefits of bisphosphonate use in patients with chronic kidney disease: a population-based cohort study
IRAS ID
212072
Contact name
Daniel Prieto-Alhambra
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
EUPAS10029, EU PAS Register Number
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
As our population ages, a growing number of patients are living with kidney disease. Kidney disease is associated with a significantly increased risk of broken bones with substantial implications for patients, NHS and society. Although there are effective drugs that reduce bone fracture risk in patients with osteoporosis, these drugs are untested in patients with kidney disease where the mechanism/s leading to bone brittleness can be different. In addition some data suggests that these therapies may worsen kidney function. Indeed, patients with kidney disease were excluded from most clinical trials of anti-osteoporosis therapies, leaving a gap in the current medical knowledge that has led some to untested use of these treatments in these patients.
To address this, and following a commissioned call for research from the National Institute for Health Research, we will use ‘real life’ data as collected in UK NHS clinical practice settings. In order to maximise the quality and completeness of the data, we would like to ask for permission to link (by NHS Digital, a government-trusted third party) NHS records to the existing UK Renal Registry.
As the data have already been collected whenever a patient is seen in the NHS, patients will not be randomized to receive a treatment. This approach will avoid exposing patients with kidney impairment to unnecessary risks such as adverse events. Rather, we will learn from previously exposed people from their anonymised medical records.
Statistical methods will be used to compare users of the most common treatment for osteoporosis (bisphosphonates) to non-users with similar characteristics. The study will offer relevant information on the risks and benefits of these drugs in patients with kidney impairment.REC name
South Central - Oxford C Research Ethics Committee
REC reference
17/SC/0073
Date of REC Opinion
9 Mar 2017
REC opinion
Favourable Opinion