Scope: Extended Forsteo Observational Study (ExFOS), a multinational, non-interventional, prospective, observational study aims to evaluate fracture outcomes, back pain (BP), compliance and health-related Quality of Life (QoL) in osteoporotic patients prescribed teriparatide (TPTD). We present treatment outcomes for patients (male or female) treated for up to 24 months in Greece.
Methods: Of the 440 patients enrolled in the study 416 (mean age 69.9±9.7 years) have performed at least one active treatment post-baseline visit. These were predominantly women (92.1%), at postmenopausal stage (99.7%). Self-reported parameters of health perception have been recorded throughout the study through validated questionnaires (EQ-5D). We report the observed percent and mean responses.
Results: Seventeen (4.1%) patients had an incident clinical fracture during follow-up. Adherence: 80% of subjects used the treatment through month 23; 45% continued use through month 24. BMD numerically increased in all sites. Indicatively, Lumbar BMD T-score (mean (S.D.)) increased from −3.39 (0.73) at baseline to −2.36 (0.63) at study end. BP history the last year before enrollment was reported by 88.9%. During treatment, all self-reported variables improved. Examples of BP frequency (% of patients with BP fairly often or almost daily) and BP severity (% with moderate-severe BP), EQ-5D Visual Analogue Scale (VAS) score and EQ-5D mobility (% reporting some or extreme problems) are depicted below.
|Baseline||3 m||6 m||12 m||18 m||24 m|
|BP frequency (%)||68.2||33.5||22.6||14.1||17||11.6|
|BP severity (%)||76.2||50.4||32.8||20.9||22.2||18.6|
|EQ-5D Mobility (%)||57.9||39.0||29.9||22.5||17.7||16.2|
Conclusions: Use of TPTD remains high almost throughout the follow-up. A decrease at month 24 may be due to prescribing (24 months/26 cartridges) particularities. Patients experience improvement in BP and QoL. Fracture rate was low. Results should be interpreted in the context of an observational study.
14 May 2016 - 17 May 2016