Hip, vertebral, and distal forearm fractures incur substantial loss in QoL and for patients with hip or vertebral fracture, QoL is markedly impaired for at least 18 months.

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Background Several studies have demonstrated low 25(OH)D3 serum levels, which could influence pathogenesis and clinical outcomes of immune-mediated diseases such as rheumatoid arthritis (RA) (1,2). Objectives In order to investigate the necessity to implement specific vitamin D patient related outcomes we performed a pilot European multicentre study, involving individuals from different countries/latitudes, to explore 25(OH)D3 serum levels and their possible correlation with disease activity and related outcomes in RA patients during winter season. Methods We enrolled 270 RA patients (not treated with vitamin D supplementation) and 180 healthy subjects as controls (CNT), from Rheumatology centers in 10 European countries. RA patients mean disease duration was 10±9 years and mean age 56±10 years. Patients informed consent was obtained before collecting blood samples. Complete medical history, health assessment questionnaire (HAQ), rheumatoid arthritis impact disease score (RAID), disease activity scale (DAS28) were recorded. 25(OH)D3 serum levels were evaluated centrally using chemiluminescence immunoassay with an automatic analyser (LIAISON, DiaSorin), and classified as normal (>30 ng/ml), insufficient (between 20 and 30 ng/ml) or deficient (<20 ng/ml) (3). Results 25(OH)D3 serum levels were significantly lower in RA patients compared to controls (median 16 vs 20 ng/ml) (p<0.0001). In particular, we registered 25(OH)D3 deficiency (<20 ng/ml) in 25% and insufficiency in 70% of RA patients. Male and female RA patients showed similar 25(OH)D3 values (median 19 vs 17 ng/ml) (p=n.s.). We found statistically significant difference in 25(OH)D3 levels between some European countries such as significantly higher 25(OH)D3 serum levels in Spanish RA patients (Canaries Islands) compared to patients from Latvia, Lithuania, Romania, Croatia, Russia and Italy (p<0.01). In agreement with previous observations (4), we found in RA patients statistically significant negative correlations between 25(OH)D3 values and HAQ (r=-0.29, p=0.03), RAID (r=-0.32, p=0.02), and DAS28 scores (r=-0.41, p=0.003), respectively. Conclusions The results of this multicentre study confirms, at least in winter time, the presence of significantly lower 25(OH)D3 serum levels in RA patients than in healthy control subjects, which seem correlated with disease activity at all latitudes in Europe. The significant negative correlations observed between 25(OH)D3 serum levels and DAS28, HAQ and RAID scores justify the need to develop specific questionnaires for patient reported outcomes (PRO) vitamin D-related, and to validate them in a large European multicentre study. References 1. Cutolo et al. Autoimmun Rev 2011;11:84-87. Aranow C. J Investig Med. 2011; 59: 881–886. 3. Holick MF. N Engl J Med 2007;357:266-81. 4. Cutolo M. Ann Rheum Dis 2013;72:473-5. Disclosure of Interest None declared DOI 10.1136/annrheumdis-2014-eular.4145

Changes in health-related quality of life (QoL) due to hip, humeral, ankle, spine, and distal forearm fracture were measured in Russian adults age 50 years or more over the first 18 months after fracture. The accumulated mean QoL loss after hip fracture was 0.5 and significantly greater than after fracture of the distal forearm (0.13), spine (0.21), proximal humerus (0.26), and ankle (0.27). Introduction Data on QoL following osteoporotic fractures in Russia are scarce. The present study evaluated the impact of hip, vertebral, proximal humerus, distal forearm, and ankle fracture up to 18 months after fracture from the Russian arm of the International Costs and Utilities Related to Osteoporotic Fractures Study. Methods Individuals age ≥ 50 years with low-energy-induced humeral, hip, clinical vertebral, ankle, or distal forearm fracture were enrolled. After a recall of pre-fracture status, HRQoL was prospectively collected over 18 months of follow-up using EQ-5D-3L. Multivariate regression analysis was used to identify determinants of QALYs loss.

Modern medications for osteoporosis (bisphosphonates, denosumab, teriparatide) are well-tolerated drugs, which can significantly lower vertebral and non-vertebral fracture risk according to prospective and observational studies in up to 10-year period. Certain drugs (denosumab, teriparatide) are active only during the treatment period and do not prevent bone loss and fracture risk after discontinuation, while such protective effect is observed in bisphosphonates. Despite impressive success of continuous 10-year denosumab treatament of severe osteoporosis, some of the recently published data suggest that vertebral fracture incidence is increased after treatment discontinuation, along with multiple vertebral fracture incidence, especially in patients with previous fractures.  Issues of osteoporosis treatment duration, sequential use of osteoporosis drugs and criteria for treatment discontinuation are now in focus of attention. European Medicines Agency (EMA) and European Calcified Tissue Society (ECTS) considered these issues in 2017. ЕМА considered fractures after denosumab discontinuation as a natural disease course and did not recommend any changes in product instruction. The main conclusion of ECTS is that the possibility of multiple fractures development after denosumab discontinuation exists, however, there is still not enough firm evidence, as well as effective countermeasures. Clinicians and patients should be aware of potential risk. Both EMA and ECTS suggest considering denosumab treatment or discontinuation after 5-year treatment period or possibly replacing with bisphosphonates. Recent data suggest that prolonged osteoporosis treatment can be done in accordance with the concept of treatment until target goal (for example, achievement of femoral T-score -2.0SD and higher).  In our review, we focus on recent data concerning the issues stated above. This topic was also discussed on Russian Osteoporosis Association (ROA) expert meeting in Saint Petersburg on 24 may 2018, chaired by ROA president, professor Olga Lesnyak and Columbia University professor, J.P. Bilezikian. As a result, an Expert Council resolution was written and introduced in the article.