Abstract
This study aimed to describe clinical outcomes in patients prescribed teriparatide and followed up for 18 months after stopping the drug in real-life conditions. The Extended Forsteo® Observational Study analysed incident clinical fractures in 6-month intervals using logistic regression with repeated measures. Changes in back pain (visual analogue scale) and health-related quality of life (HRQoL; EQ-5D questionnaire) were analysed using mixed models for repeated measures. Patients were analysed if they had a post-baseline visit, regardless of whether and for how long they took teriparatide. Of 1531 patients analysed (90.7% female, mean age: 70.3 years), 76 (5.0%) never took teriparatide. Median treatment duration was 23.6 months. The adjusted odds of clinical fracture decreased by 47% in the > 12- to 18-month treatment period (p = 0.013) compared with the first 6-month period, with no statistically significant reduction in the > 18- to 24-month interval. The clinical fracture rate remained stable during the 18 months’ post-teriparatide, when approximately 98% of patients took osteoporosis medication (51% bisphosphonates). Clinical vertebral fractures were reduced at every time period compared with the first 6 months. Adjusted mean back pain scores decreased and EQ-5D scores increased significantly at each post-baseline observation. In a real-life clinical setting, the risk of clinical fractures declined during 24 months of teriparatide treatment. This reduction was maintained 18 months after stopping teriparatide. In parallel, patients reported significant improvements in back pain and HRQoL. The results should be interpreted in the context of the non-controlled design of this observational study.
Highlights
Teriparatide is an osteoanabolic agent that stimulates osteoblastic bone formation to improve bone quality and mass [1]
A high proportion of patients reported having fractures in the 12 months before baseline: 47.6% had any type of fracture and 41.6% had a vertebral fracture (Table 1)
Our findings showed that the reduced risk of clinical fracture was maintained even after teriparatide had been discontinued and most patients had switched to another osteoporosis medication
Summary
Teriparatide (recombinant human parathyroid hormone, Forsteo®) is an osteoanabolic agent that stimulates osteoblastic bone formation to improve bone quality and mass [1]. Treatment of postmenopausal women with severe osteoporosis It subsequently received additional approval for the treatment of osteoporosis in men, and for the treatment of osteoporosis associated with glucocorticoid therapy in men and women at risk of fracture. The Extended Forsteo® Observational Study (ExFOS) was a non-interventional, prospective, single-cohort, observational study conducted in eight European countries [14] that addressed the need for a large real-life clinical practice study of teriparatide treatment after the update of the teriparatide European label, i.e. the extended treatment duration to 24 months, as well as the newly approved therapeutic indications in the context of osteoporosis treatment guidelines in the participant countries. We report the incidence of clinical vertebral and non-vertebral fractures, as well as changes in back pain and health-related quality of life (HRQoL) over 42 months (i.e. up to 24 months of teriparatide treatment and 18 months of follow-up after stopping teriparatide)
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