FP601DECREASED OSTEOCALCIN LEVELS AND INCREASED MORTALITY IN HEMODIALYSIS PATIENTS WITH DIABETES MELLITUS

n/

Economic Burden of Osteoporotic Patients with Fracture: Effect of Treatment With or Without Calcium/Vitamin D Supplements

none7Background: Fractures represent the most important complication of osteoporosis, in terms of loss of independency, chronic pain, increased risk of mortality, but also high healthcare costs.Objective: To assess healthcare costs in an Italian cohort of osteoporotic patients with a fracture with and without specific osteoporosis treatment and supplementation with calcium/vitamin D.Methods: This retrospective observational study used data from administrative databases of five Local Health Units in Italy. Patients >= 50 years of age and hospitalized for vertebral or hip fracture occurring from 01/01/2011 to 31/12/2015 were included. Patients were then classified as "untreated" and "treated" if they had been treated or not with drugs for fracture prevention after the index fracture. We also identified subjects that were only treated with drugs for fracture prevention, "osteoporosis drug only" group, compared to the "osteoporosis drug plus calcium/vitamin D" group, in which calcium and/or vitamin D were also in combination. Healthcare cost analysis included drug expenditure, hospitalization costs (excluding costs related to the hospitalization for the index fracture) and outpatient service costs.Results: Three thousand four hundred and seventy-five patients were included in the present study, most of whom (58.5%) had received specific osteoporosis treatment after index fracture. Among treated patients, the vast majority (83.6%) received supplementation with calcium/vitamin D. Mean annual healthcare cost per patient was (sic)9,289.85 in the untreated group and (sic)4,428.26 for treated subjects (p < 0.001); mean annual healthcare cost for the osteoporosis drug-only group was higher compared to the osteoporosis drug plus calcium/ vitamin D group (sic)5,976.88 vs (sic)4,124.74, respectively, p < 0.001). Hospitalization costs accounted for the majority of total costs in all groups of patients.Conclusion: Healthcare costs in patients with osteoporotic fractures were significantly lower in those receiving osteoporosis treatment compared to untreated patients with even lower costs observed in patients that were also receiving calcium/vitamin D supplements.noneDegli Esposti, Luca; Saragoni, Stefania; Perrone, Valentina; Sella, Stefania; Andretta, Margherita; Rossini, Maurizio; Giannini, SandroDegli Esposti, Luca; Saragoni, Stefania; Perrone, Valentina; Sella, Stefania; Andretta, Margherita; Rossini, Maurizio; Giannini, Sandr

Use of antiosteoporotic drugs and calcium/vitamin D in patients with fragility fractures: impact on re-fracture and mortality risk

To evaluate the impact of pharmacological treatment in osteoporosis patients with recent fracture and to assess the incidence of subsequent fracture and all-cause mortality

The initiative on hip fractures of the Veneto Region

Objective: to assess the prevalence of the most relevant environmental and individual risk factors in subjects with a recent hip fracture was the aim of this observational study promoted by the Health Authorities of the Regione Veneto (Italy). Methods: patients aged > 60 years of both genders with a recent hip fracture not associated with malignancies, were administered questionnaires on dietary habits, sun exposure, disability score. A complete family, pharmacological and pathology history was collected together with previous falls, details of the fracture index, anthropometric data. In a subgroup of patients blood was taken for the measurements of serum 25 hydroxy-vitamin D (25OHD). Results: the study includes 704 patients (573 women and 131 men). Mean age was 81±8 years (range 60-102). Severe prefracture disability was a common feature (58%) associated with multiple co-morbidities (84%), more frequently cardiovascular and neurological diseases, and specific medications. In a large proportion (86%) of the patients environmental or individual risk factors for falling were found. Vitamin D insufficiency was quite common, particularly in the regional Health Districts were strategies for preventing vitamin D deficiency were not implemented. Only a small proportion (17%) of the study population had been evaluate and treated for osteoporosi

The Potential Impact of Inducing a Restriction in Reimbursement Criteria on Vitamin D Supplementation in Osteoporotic Patients with or without Fractures

: In October 2019, the Italian Drug Agency (AIFA) restricted reimbursement criteria for vitamin D (VD) use outside the osteoporosis setting (Note 96). However, whether this restriction could also have involved patients at risk for or with osteoporotic fractures has not yet been investigated. We retrospectively analyzed databases from five Italian Local Health Units. Patients aged ≥50 years with either at least one prescription for osteoporosis treatment or with fragility fractures and evidence of osteoporosis from 2011 to 2020 were included. The proportion of subjects with an interruption in VD treatment before and after the introduction of the new reimbursement criteria and predictors of this interruption were analyzed. A total of 94,505 patients (aged 69.4 years) were included. Following the introduction of Note 96, a 2-fold (OR 1.98, 95% CI: 1.92-2.04) increased risk of VD discontinuation was observed. These findings were independent of seasonal variation, osteoporosis treatment patterns, as well as other confounding variables. However, a higher rate of interruption was observed in patients without vertebral/femur fracture (37.8%) vs. those with fracture (32.9%). Rheumatoid arthritis, dyslipidemia and previous fracture were associated with a lower risk of VD interruption, while stroke increased the risk of VD interruption. Our results highlight that a possible misinterpretation of newly introduced criteria for reimbursement restrictions in VD outside of osteoporosis have resulted in an inadequate level of VD supplementation in patients with osteoporosis. This undertreatment could reduce the effect of osteoporosis therapies leading to increased risk of negative outcome

Calcimimetic and vitamin D analog use in hemodialyzed patients is associated with increased levels of vitamin K dependent proteins

Matrix Gla protein (MGP) and bone Gla protein (BGP) are two vitamin K-dependent proteins (VKDPs) involved in the regulation of vascular calcification (VC). We carried out a secondary analysis of the VIKI study to evaluate associations between drug consumption and VKDP levels in 387 hemodialyzed patients. The VIKI study assessed the prevalence of vitamin K deficiency in hemodialysis patients. We evaluated drug consumption, determined BGP and MGP levels, and verified the presence of any vertebral fractures (VF) and VC by spine radiographs. Total BGP levels were twice as high with calcimimetics versus no calcimimetics (290 vs. 158.5 mcg/L, p < 0.0001) and 69 % higher with vitamin D analogs (268 vs. 159 mcg/L, p < 0.0001). Total MGP was 19 % higher with calcimimetics (21.5 vs. 18.1 mcg/L, p = 0.04) and 54 % higher with calcium acetate (27.9 vs. 18.1 mcg/L, p = 0.003); no difference was found with vitamin D analogs (21.1 vs. 18.3 mcg/L, p = 0.43). Median Total BGP level was 29 % lower in patients with a parts per thousand yen1 VF (151 vs. 213 mcg/L, p = 0.0091) and 36 % lower in patients with VC (164 vs. 262.1 mcg/L, p = 0.0003). In non-survivors, median BGP and MGP were lower, but only for MGP this difference reached the statistical significance (152 vs. 191 mcg/L, p = 0.20 and 15.0 vs. 19.7 mcg/L, p = 0.02, respectively). Pending studies on vitamin K supplementation, calcimimetics, and vitamin D analogs may play a role in preserving vitamin K-dependent protein activity, thus contributing to bone and vascular health in CKD patients

Declining trends in the incidence of hip fractures in people aged 65years or over in years 2000-2011

The aim of this study was to explore hip fracture (HFx) incidence in the Veneto Region of Italy, looking at potential differences with the national data

Low vitamin K1 intake in haemodialysis patients

Background &amp; aims: Vitamin K acts as a coenzyme in the g-carboxylation of vitamin K-dependent proteins,including coagulation factors, osteocalcin, matrix Gla protein (MGP), and the growth arrest-specific6 (GAS6) protein. Osteocalcin is a key factor for bone matrix formation. MGP is a local inhibitor of softtissue calcification. GAS6 activity prevents the apoptosis of vascular smooth muscle cells. Few data onvitamin K intake in chronic kidney disease patients and no data in patients on a Mediterranean diet areavailable. In the present study, we evaluate the dietary intake of vitamin K1 in a cohort of patientsundergoing haemodialysis.Methods: In this multi-centre controlled observational study, data were collected from 91 patients aged&gt;18 years on dialysis treatment for at least 12 months and from 85 age-matched control subjects withnormal renal function. Participants completed a food journal of seven consecutive days for the estimationof dietary intakes of macro- and micro-nutrients (minerals and vitamins).Results: Compared to controls, dialysis patients had a significant lower total energy intake, along with alower dietary intake of proteins, fats, carbohydrates, fibres, and of all the examined minerals (Ca, P, Fe,Na, K, Zn, Cu, and Mg). With the exception of vitamin B12, vitamins intake followed a similar pattern,with a lower intake in vitamin A, B1, B2, C, D, E, folates, K1 and PP. These finding were confirmed alsowhen normalized for total energy intake or for body weight.In respect to the adequate intakes recommended in the literature, the prevalence of a deficient vitamin Kintake was very high (70e90%) and roughly double than in controls. Multivariate logistic model identifiedvitamin A and iron intake as predictors of vitamin K deficiency