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 open-label, noncontrolled design of the study.

Fig. 1

Percent of patients on teriparatide treatment at each time point in the study. Reimbursement in most participant countries is limited to 18 pen devices (i.e., ≈17 months treatment; see text)

Fig. 2

Number and percent patients with incident fractures in each 6-month period by fracture type. * P < 0.05, ** P < 0.10. Adjusted models by age, prior bisphosphonate use, and history of fracture in the last 12 months before starting teriparatide. *** Forearm/wrist, hip, humerus, leg, and sternum/ribs

Fig. 3

Adjusted change in back pain from baseline: 100 mm VAS. Model includes back pain VAS baseline value, age, duration of prior bisphosphonate therapy, rheumatoid arthritis, and history of fracture in the 12 months prior to starting teriparatide therapy. All values: P < 0.001 compared to baseline. Actual unadjusted values of mean (SD) at 0, 3, 6, 12, and 18 months were 57.7 (26.6), 42.8 (25.1), 38.2 (25.4), 34.6 (25.7), and 31.6 (25.6) mm, respectively

Fig. 4

Change in HRQoL. EQ-VAS model includes EQ-VAS baseline value, age, duration of prior bisphosphonate therapies, rheumatoid arthritis, and history of fracture in the 12 months prior to starting teriparatide therapy. All values: P < 0.001 compared to baseline. Actual unadjusted values of mean (SD) at 0, 3, 6, 12, and 18 months were 51.7 (22.0), 58.8 (19.9), 61.8 (20.4), 64.8 (22.0), and 68.1 (21.7) mm, respectively