Arch Hellen Med, 29(4), July-August 2012, 454-460
The European Forsteo Observational Study (EFOS)
K. Aloumanis,1 V. Drossinos,1 D. Trikka,1 D. Karras2 for the Hellenic EFOS study
OBJECTIVE The European Forsteo Observational Study (EFOS) examined the long-term fractures, back pain (BP), health-related quality of life (HRQoL) and compliance with treatment in post-menopausal women with osteoporosis (OP) treated with teriparatide (TPTD) for the maximum approved period (18 months), with follow-up for a further 18 months. This paper describes the 18 month follow-up outcomes of Greek patients completing TPTD treatment.
METHOD EFOS, a 3-year, multinational, observational study recorded the incidence of clinical vertebral and non-vertebral fractures, BP [using a 100 mm Visual Analogue Scale (VAS)], and HRQoL [using the EuroQol Standardized Questionnaire (EQ-5D)]. Changes from baseline in BP and EQ parameters were analyzed using a repeated measures model. Improvement over the baseline in frequency and severity of BP and limitations in activity due to BP were assessed using the sign test.
RESULTS Of the 301 Greek women aged 69.5±8.5 years enrolled in the study, 83.7% reported previous OP treatment. A sustained decrease in BP and concurrent limitation of movement, a reduction of days in bed, improvement of mobility and increase in the scale on self-reported QoL were observed 18 months after completion of treatment with TPTD. These findings should be interpreted in the context of a noncontrolled observational study.
CONCLUSIONS An 18-month course of TPTD appears to have a beneficial effect on BP, mobility and QoL that is sustained up to 18 months after completion of treatment.
Key words: Back pain, Compliance, Osteoporosis, Quality of life, Teriparatide.