ECTS Abstracts (2015) 1 P362

Fracture incidence and changes in quality of life and back pain in patients with osteoporosis treated with teriparatide: 24-month results from the extended Forsteo Observational Study (ExFOS)

Bente Langdahl1, Östen Ljunggren2, Claude Laurent Benhamou3, Georgios Kapetanos4, Tomaz Kocjan5, Nicola Napoli6, Tatjana Nicolic7, Helmut Petto8, Thomas Moll8 & Erik Lindh8

1University Hospital, Aarhus, Denmark; 2University Hospital, Uppsala, Sweden; 3Orléans Hospital, Orléans, France; 4Papageorgiou General Hospital, Tessaloniki, Guadeloupe; 5University Medical Centre, Ljubljana, Slovenia; 6University Campus Bio-Medico, Rome, Italy; 7University Hospital, Zagreb, Croatia; 8Eli Lilly and Company, Europe, Sweden.

Background: The aim was to describe the fracture outcomes, health-related quality of life (HR-QoL) and back pain (BP) of patients with osteoporosis treated with teriparatide for up to 24 months in the ExFOS study.

Methods: Prospective observational study in patients with osteoporosis from eight European countries. Treatment duration was up to 24 months. Low-trauma and any type of clinical vertebral and non-vertebral fractures were collected at each follow-up visit. HR-QoL was measured using EQ-5D. BP was measured using a 100 mm visual analog scale (VAS) and a BP questionnaire.

Results: 1607 patients were enrolled, and 1,454 received at least one dose of teriparatide. Of these, 1,318 (90.6%) were female, and 210 (14.4%) were taking glucocorticoids. Mean age was 70.2 years. At baseline, 65.5% of patients had 2 or more pre-existing fractures.11.3% of the study participants were osteoporosis-treatment naïve. Mean treatment duration with teriparatide was 21 months. 67 patients (4.6%) sustained a total of 77 incident low-trauma fractures (23% vertebral, 77% non-vertebral). A 53% decrease in the odds of low-trauma clinical fractures in the last 18-24-month period compared with the first 6-month period was observed (p<0.05). The mean total EQ-5D Health state increased from baseline to 24 months (p<0.001). A reduction of BP was observed after 3 months (-10.2 mm) and sustained up to 24 months (-23.1 mm) (p<0.001). At baseline, 90.8% of patients experienced BP in the month preceding study entry. This frequency was reduced to 79.7% and 70.2% after 12 and 24 months respectively. Moderate/severe BP was reduced from 81.1% of the patients at baseline to 43.1% at 24 months.

Conclusion: Treatment with teriparatide in the ExFOS cohort resulted in a reduction of fractures and back pain and improvement of health-related quality of life over time. These results should be interpreted in the context of a non-controlled observational study.

Disclosure: AB is a full time employee of Eli Lilly Sweden. This work was funded by Eli Lilly and Company Europe.