Abstract
We describe the pre-planned interim analysis of fracture outcomes, health-related quality of life (HRQoL) and back pain in patients with severe osteoporosis treated with teriparatide for up to 24 months in the Extended Forsteo (Forsteo® is a registered trade name of Eli Lilly and Company) Observational Study (ExFOS), a prospective, multinational, observational study. Data on incident clinical fractures, HRQoL (EQ-5D questionnaire) and back pain [100 mm visual analogue scale (VAS)] were collected. The number of patients with fractures was summarised in 6-month intervals and fracture rate over each 6-month period was assessed using logistic regression for repeated measures. Changes from baseline in EQ-5D and back pain VAS were analysed using mixed models for repeated measures. Of 1454 patients in the active treatment cohort, 90.6 % were female and 14.4 % were taking glucocorticoids. During teriparatide treatment (median duration 23.7 months), 103 patients (7.1 %) sustained a total of 122 incident clinical fractures (21 % vertebral, 79 % non-vertebral). A 49 % decrease in the odds of fractures and a 75 % decrease in the odds of clinical vertebral fractures were observed in the >18- to 24-month period versus the first 6-month period (both p < 0.05). EQ-5D scores and back pain VAS scores were significantly improved from baseline at each post-baseline observation during teriparatide treatment. In conclusion, patients with severe osteoporosis showed a significant reduction in the incident fracture rate during 24 months of teriparatide treatment in routine clinical practice, accompanied by a significant improvement in HRQoL and reduction in back pain. Results should be interpreted in the context of the non-controlled design of this observational study.Electronic supplementary materialThe online version of this article (doi:10.1007/s00223-016-0143-5) contains supplementary material, which is available to authorized users.
Highlights
Osteoporosis is characterised by low bone mineral density (BMD) and deterioration in bone quality resulting in increased bone fragility and predisposing patients to fracture
We describe the pre-planned interim analysis of fracture outcomes, health-related quality of life (HRQoL) and back pain in patients with severe osteoporosis treated with teriparatide for up to 24 months in the Extended Forsteo (ForsteoÒ is a registered trade name of Eli Lilly and Company) Observational Study (ExFOS), a prospective, multinational, observational study
There were 34 patients with at least one adverse event leading to death (2.1 % of all 1611 enrolled patients); none of these deaths were considered related to the study drug by the reporting investigators. This analysis of the active treatment phase of the Extended ForsteoÒ Observational Study (ExFOS) study confirms the effectiveness of teriparatide treatment for up to 24 months in reducing the incidence of clinical fractures, improving HRQoL and reducing back pain in patients with severe osteoporosis
Summary
Osteoporosis is characterised by low bone mineral density (BMD) and deterioration in bone quality resulting in increased bone fragility and predisposing patients to fracture. In 2010, the estimated number of people in the European Union (EU) with osteoporosis was 27.6 million and the annual number of new fragility fractures was 3.5 million; these included 610,000 hip fractures, 560,000 forearm fractures and 520,000 vertebral fractures [1] Osteoporotic fractures, especially those of the hip and vertebrae, can cause pain and functional disability, reduce. The reduction in the risk of new fractures seen in the RCT was confirmed in observational studies conducted in real-life settings, such as the European ForsteoÒ Observational Study (EFOS), which showed a reduced incidence of clinical fractures, improved HRQoL and reduced back pain during up to 18 months of treatment with teriparatide in postmenopausal women with severe osteoporosis [10]
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