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Summary: This observational study evaluated the occurrence of nonvertebral fragility fractures (NVFX) in over 4,000 men and women with osteoporosis treated with teriparatide (TPTD). The incidence of new NVFX decreased for patients receiving TPTD treatment for greater than 6 months. No new significant safety findings were observed in this large trial. Introduction: The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study evaluated the occurrence of NVFX in patients receiving TPTD for osteoporosis in a real-world setting. Methods: DANCE is a multicenter, prospective, observational trial that examined the long-term effectiveness of TPTD in men and women with osteoporosis whom study physicians judged to be suitable for TPTD therapy. Patients received 20 μg TPTD per day by subcutaneous injection for up to 24 months and were followed for 24 months after treatment cessation. The incidence of patients experiencing a new NVFX, defined as a fracture associated with low trauma, was evaluated during four 6-month periods in both the treatment and cessation phases with >0 to ≤6 months serving as the reference. We also observed the spectrum and occurrence of serious adverse events. Results: Of the 4,167 patients enrolled, 4,085 took one or more doses of TPTD (safety population); 3,720 were included in the efficacy analysis. The incidence of patients experiencing a NVFX was 1.42, 0.91, 0.70, and 0.81 % for the four treatment periods, respectively, and 0.80, 0.68, 0.33, and 0.33 % for the four periods after treatment cessation. Differences for each period were statistically significant compared with the reference period (first 6-month interval, each p < 0.05). No new significant safety findings were observed. Conclusions: In this study, the incidence of NVFX decreased for patients receiving TPTD for all three treatment periods >6 months compared to 0 to ≤6 months, and this trend persisted throughout the cessation phase. TPTD was generally well tolerated. [ABSTRACT FROM AUTHOR]

The increasing frequency and severity of wildfires poses human health risks, especially for those within burnt regions. The potential health effects of fire ash on farmworkers in orchards via inhalation exposure after fire is rarely studied. After the 2017 Thomas Fire, in Ventura County (California, USA), fire ash and corresponding soil samples were collected from several impacted orchards and analyzed for eight trace elements (TEs) and 16 polycyclic aromatic hydrocarbons (PAHs). Results indicate that except for mercury (Hg), the concentrations of TEs and PAHs were higher in ash samples compared with the corresponding soil samples. In general, ash samples showed greater potential to expose farmworkers to health risks than the corresponding soil samples. One site had particularly high concentrations of As (778 mg kg -1 ), Cr (629 mg kg -1 ), and Cu (499 mg kg -1 ) in the ash. This location corresponds to a house which was burned during the Thomas Fire, which might have contained chromated copper arsenate as a wood preservative. Therefore, the existence of construction materials in orchards could add hazardous materials to ash deposited on soil. Furthermore, a monitored dust generation experiment was designed to obtain the particle emission factors (PEF) of soil and ash, which is an essential parameter for the calculation of inhalation health risks. A two-fold difference in the PEFs was found between ash and the corresponding soil sample. Hence, health risks through inhalation exposure from fire ash may be underestimated if the default PEF suggested by the US Environmental Protection Agency is used., (Copyright © 2020 Elsevier Ltd. All rights reserved.)