Data from the post-teriparatide cohort showed there was no evidence of further change in the odds of fracture during the 18 months after stopping teriparatide. The back pain results for the post-teriparatide cohort were similar to those for the total study cohort (data not shown). Safety

A total of 351 adverse events were spontaneously reported by the physicians before discontinuation of teriparatide. Of these, 121 (34.5%) were serious, 173 (49.3%) were considered possibly related to study medication, and 22 (6.3%) led to death. The most common adverse events reported were nausea (5.4%) and headache (4.3%), and the most common serious adverse events were death, transient ischaemic attack (4.1% each), arrhythmia, myocardial infarction, cerebrovascular accident, dyspnoea and hypertension (2.5% Navitoclax purchase each). After discontinuation of teriparatide, 31 adverse events were reported, all occurring either once or

twice. Of these, 22 (71.0%) were serious, five (16.1%) were considered possibly related to study medication and ten (32.3%) led to death. Discussion EFOS is the first observational study to https://www.selleckchem.com/products/INCB18424.html report fracture rates together with back pain in postmenopausal women with severe osteoporosis in routine clinical practice both during teriparatide treatment for up to 18 months, and in the subsequent 18-month post-teriparatide period, when the majority of patients took other osteoporosis medications, mainly bisphosphonates. We observed beneficial Coproporphyrinogen III oxidase effects on the adjusted odds of fracture during teriparatide treatment, with no evidence of further change in odds of fracture after teriparatide was discontinued. The adjusted odds of sustaining any clinical fracture or a vertebral fracture were significantly lower after 12 to <18 months of teriparatide treatment compared with the first 6 months. In addition, the adjusted odds of non-vertebral fracture were significantly

lower after 24 to <30 months. Patients who had a fracture in the 12 months before baseline or who were previously treated with bisphosphonates were more likely to fracture during the study, probably reflecting the higher risk of fracture in these two patient subgroups [2]. The reduction in fractures was accompanied by a reduction in back pain during teriparatide treatment, with the changes in back pain being maintained for at least 18 months after teriparatide was discontinued. Given the teriparatide reimbursement criteria in the participant countries, the patients taking part in EFOS had severe osteoporosis and a very high risk of fracture as indicated by their low BMD values, high number of previous fractures and presence of other risk factors at baseline. Moreover, many patients had chronic co-morbidities (32.5%) and/or took concomitant medications (63.8%) that would have prevented them from taking part in controlled trials.