The COSMOS Project

From Jorge B Cannata-Andía, ERA-EDTA Secretary-Treasurer and Chairman and Principal Investigator of COSMOS Project

The derangements in bone and mineral metabolism are associated with increased morbidity and mortality. Poorly-controlled parathyroid function contributes not only to bone problems but also to an increase in the risk of vascular and valvular calcifications, with influences in the cardiovascular death risk in the dialysis population. These facts emphasis the need for more careful monitoring and better management of secondary hyperparathyroidism. Unfortunately most of the clinical studies performed on renal osteodystrophy have been conducted on specific populations but these results do not reflect what happens in the current management of renal osteodystrophy in Europe.

In order to investigate the current management of secondary hyperparathyroidism in Europe, we have initiated a pan-European prospective observational SHPT outcomes study (COSMOS: “Current Management of Secondary Hyperparathyroidism – A Multi-centre Observational Study”). The COSMOS study will provide vital data on current clinical practices across Europe at 250 hospitals, recruiting 5000 prevalent and incident haemodialysis patients in European countries and will provide valuable information and build a 3-year prospective database looking at bone mineral metabolism disturbances and their associations with morbidity and mortality which will be transferred to the ERA-EDTA Registry at the end of the study.

The study has been designed by and will be lead by the Bone and Mineral Research Unit in Oviedo (Spain) in collaboration with National coordinators of all countries involved. COSMOS will be sponsored and endorsed by the Instituto “Reina Sofía” de Investigación, the Fundación Renal and ERA-EDTA. This exciting initiative will also be carried out in collaboration with NDT-Educational and all data will be entered into a web-based database using this ERA-EDTA educational website, (NDT-Educational www.ndt-educational.org), as the main access gateway. We hope the final website will be ready for data entry in early October.

The study has already commenced the centre selection and randomisation process in some of the European countries, including France, Germany, UK, Spain, Italy, Portugal, the Netherlands, Austria and Switzerland and furthermore, Belgium, Poland, Romania, Czech Republic, Slovenia, Norway, Finland, Sweden and Denmark have now been included in the study

Being completely non-interventional, COSMOS will allow the estimation of the clinical outcomes and also the prevalence of ‘Kidney Disease Outcomes Quality Initiative' (K/DOQI) guideline achievement in a representative sample of European haemodialysis subjects, depending on type of dialysis used, type of centre and time on dialysis. Further objectives will include the association of bone mineral markers (PTH, Ca, PO4, CaxPO4) classified by achievement of K/DOQI targets with mortality and overall cardiovascular hospitalization as well as specific cardiovascular outcomes, parathyroidectomy, and manifest bone disease (including incidence of symptomatic bone fractures), hospitalisations and vascular access.

We are convinced that COSMOS will give us a unique opportunity to gather extremely useful data on bone and mineral metabolism and current clinical practice across Europe which will help us in the better management of renal osteodystrophy.