Reduction in Fracture Rate and Back Pain and Increased Quality of Life in Postmenopausal Women Treated with Teriparatide: 18-Month Data from the European Forsteo Observational Study (EFOS)

Abstract

The European Forsteo Observational Study was designed to examine the effectiveness of teriparatide in postmenopausal women with osteoporosis treated for up to 18 months in normal clinical practice in eight European countries. The incidence of clinical vertebral and nonvertebral fragility fractures, back pain, and health-related quality of life (HRQoL, EQ-5D) were assessed. Spontaneous reports of adverse events were collected. All 1,648 enrolled women were teriparatide treatment-naive, 91.0% of them had previously received other anti-osteoporosis drugs, and 72.8% completed the 18-month study. A total of 168 incident clinical fractures were sustained by 138 (8.8%) women (821 fractures/10,000 patient-years). A 47% decrease in the odds of fracture in the last 6-month period compared to the first 6-month period was observed (P \ 0.005). Mean back pain VAS was reduced by 25.8 mm at end point (P \ 0.001). Mean change from baseline in EQ-VAS was 13 mm by 18 months. The largest improvements were reported in the EQ-5D subdomains of usual activities and pain/discomfort. There were 365 adverse events spontaneously reported, of which 48.0% were considered related to teriparatide; adverse events were the reason for discontinuation for 79 (5.8%) patients. In conclusion, postmenopausal women with severe osteoporosis who were prescribed teriparatide in standard clinical practice had a significant reduction in the incidence of fragility fractures and a reduction in back pain over an 18-month treatment period. This was associated with a clinically significant improvement in HRQoL. Safety was consistent with current prescribing information. These results should be interpreted in the context of the openlabel, noncontrolled design of the study.Keywords Osteoporosis Á Teriparatide Á Fracture Á Back pain Á Quality of life Osteoporosis, a chronic skeletal disorder characterized by reduced bone quantity and quality, increases bone fragility and predisposes patients to fractures, mainly at the spine, hip, wrist, and proximal humerus. In the year 2000, the number of osteoporotic fractures worldwide was estimated to be 9 million, with 61% of these occurring in women [1]. Osteoporotic fractures substantially impair health-related quality of life (HRQoL) [2,3] and lead to increased

The impact of teriparatide adherence and persistence on fracture outcomes

“…The inverse relationship found in this study between therapy exposure and non-vertebral fracture risk is generally consistent with results reported in TPTD randomized clinical trials and prospective observational studies [13][14][15]. The post hoc analysis of the TPTD pivotal RCT data showed that longer duration of exposure was associated with reduced risk of non-vertebral fractures, where the hazard ratio of TPTD 20 μg/day versus placebo was about 65% at the end of 6 months and decreased 7.6% each month, and by the end of 24 months hazard ratio was about 20% [13].…”

“…For TPTD, a post hoc analysis of the pivotal, randomized clinical trial data reported that longer duration of TPTD decreased the risk of non-vertebral fracture [13]. The association between length of exposure to TPTD and lower risk of fracture has also been reported from observational trials in the USA [14] and in Europe [15]. Similar data on real-world TPTD patients in the USA are lacking, however, as previous research focused on patient characteristics and treatment adherence [16,17].…”

Safety of osteoanabolic therapy: A decade of experience

“…The landmark trial conducted by Neer and colleagues (20) found that only 6% of patients taking teriparatide withdrew before the end of the study; high rates of persistence have also been found in subsequent studies in the United States and Canada. (28,(86)(87)(88) Trials that have reported compliance rates of PTH(1-84) demonstrate a range of 75% to 97.6% compliance (30,32,84,89) ; in the TOP study, 64% of the PTH-treated cohort and 70% of the placebo arm completed the study. (31) A British observational study showed a persistence rate of 87% at 12 months of treatment; this was likely influenced by the comprehensive education and follow-up program provided to each patient on PTH.…”

2010 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada: summary

“…Both calcitonin and teriparatide may decrease the pain associated with vertebral fractures. 39,40 Few studies of men have assessed the reduction of fracture rate as a primary outcome.…”