The changes in fracture risk, back pain and HRQoL during 18 month

The changes in fracture risk, back pain and HRQoL during 18 months of teriparatide treatment in EFOS have been previously https://www.selleckchem.com/products/ly3039478.html reported [15]. Methods Study design and patients The study design and characteristics of the EFOS patient population have been described previously [16]. this website Briefly, 1,649 postmenopausal women with a diagnosis of osteoporosis who were about to initiate teriparatide treatment were enrolled in eight European countries (Austria, Denmark, France, Germany, Greece, Ireland, the Netherlands, and Sweden). Patients were followed for the duration of their teriparatide treatment, which they could discontinue at any time, and were asked to return

for two additional visits after they discontinued teriparatide. Patients were not included if they were currently being treated with an investigational drug or procedure, or had any contraindications Duvelisib chemical structure as described in the

teriparatide label. Because this was an observational study, there were no further restrictions for the selection of patients. Patients gave written informed consent prior to enrolment and were able to withdraw without consequence at any time. The study was approved by local ethics committees or review boards, depending on local requirements. Data collection At the baseline visit, patient demographic characteristics, risk factors for osteoporosis and falls, osteoporosis therapies and disease status were recorded [16]. The women attended visits at baseline and at approximately 3, 6, 12 and 18 months after teriparatide initiation, and at 6 and 18 months after discontinuing teriparatide treatment. Incident OSBPL9 clinical vertebral and non-vertebral fractures, the primary study endpoint, were diagnosed and confirmed by review of the original X-rays and/or the radiology or surgical reports at the investigational site. A new or worsened vertebral fracture was defined from the presence of a confirmed radiographic vertebral fracture associated with signs and/or symptoms, such as acute or severe back pain, suggestive of a vertebral fracture [17]. Back pain was self-assessed by patients at each visit using a back pain questionnaire

detailing frequency and severity in the past month, limitations of activities and days in bed due to back pain [15]. Patients also rated their back pain severity using a horizontal 100 mm visual analogue scale (VAS), ranging from 0 mm (no back pain) to 100 mm (worst possible back pain). This type of VAS is reliable and reproducible for the measurement of pain [18]. Spontaneously reported adverse events were collected throughout the study. Statistical analysis Data were analysed for the total study cohort, which included all patients with a baseline visit and at least one follow-up visit. In addition, the post-teriparatide cohort included those patients who discontinued teriparatide and had at least one post-teriparatide follow-up visit. Results for the active treatment period have already been published [15].

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