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Defining normal bone turnover by mortality risk: a study of bone alkaline phosphatase in haemodialysis patients

Lead investigator:
Dr Edmund Lamb, Chief Investigator, elamb@nhs.net
Dr Michael Delaney, Principal Investigator, michael.delaney1@nhs.net

Project contacts:
Professor Ken Farrington, Co-Investigators, ken.farrington@nhs.net
Dr Damian Fogarty, Co-Investigators, damian.fogarty@belfasttrust.hscni.net
Dr Paul Stevens, Co-Investigators, pstevens@nhs.net
Sarah Knight, Co-Investigator/Research Nurse, sknight6@nhs.net
Zara Garratt, Clinical Trial Administrator, zara.garratt@nhs.net


Project website(s):
alphastudy.org.uk

People with kidney disease develop abnormalities of the day to day routine maintenance of their bones and the metals, minerals and chemical messengers associated with bone health. This may cause bone disease but may also lead to blood vessels becoming ‘furred-up’ or hardened with calcium. These hardened vessels can ultimately cause death or disability due to cardiovascular disease (e.g. strokes, heart attacks, amputations).

In clinical practice these bone and mineral abnormalities are managed using a range of treatments (e.g. vitamin D and phosphate binders). The initiation and dose of drugs given are largely guided by laboratory tests, including measurement of a chemical messenger called parathyroid hormone. However, parathyroid hormone is not a good marker for bone disease in people who also have kidney failure. There is some concern that treatments guided by parathyroid hormone may actually make the underlying condition worse. At present most members of the renal multidisciplinary team along with the patients spend considerable time adjusting treatment that has a poor scientific basis using our current bone-mineral markers. Alternative markers are needed. One such marker is called bone-specific alkaline phosphatase; the study believes this marker may more accurately reflect the disorders of bone and minerals in this situation.

Little is known about whether bone alkaline phosphatase predicts outcomes in people with kidney failure. The plan is to measure this marker in people receiving haemodialysis to establish whether it can predict outcomes (overall death rate, cardiovascular death rate and cardiovascular disease (e.g. heart attacks). Patients will have a simple blood test taken whilst on dialysis. We will then monitor their condition over the next three years and see whether there is any relationship between the marker levels and outcomes such as heart disease and strokes. This study hopes to identify an optimal ‘healthy’ level of the marker which could then become a treatment target in future studies.