ECE2016 Eposter Presentations Bone & Osteoporosis (40 abstracts)
From EFOS to ExFOS, active treatment phase – similarities and differences of the Greek cohorts’ results
Kyriakos Aloumanis 1 , Panagiotis Kokkoris 2 , Andreas Kleisiounis 3 , Evanthia Kofini 1 , Konstantinos Karachalios 1 , Vangelis Drossinos 1 & Georgios Kapetanos 4
1Department of Medical Research, Pharmaserve-Lilly SACI, Kifissia Athens, Greece; 2Private office, Athens, Greece; 3Private office, Chalkida, Greece; 43rd Orthopedics University Clinic, Papageorgiou General Hospital, Thessaloniki, Greece.
Introduction: Extended Forsteo® Observational Study (ExFOS), a multinational, non-interventional, prospective, observational study, designed to evaluate fractures, back pain (BP), adherence and health-related quality of life (QoL) in teriparatide (TPTD) treated patients, based on the extension of treatment duration (24 months) and the addition of new indications (glucocorticoid-induced and male osteoporosis) was compared with EFOS.
Methods/design: Baseline data showed that Hellenic EFOS patients share similarities and noticeable differences with female ExFOS patients1. To further evaluate such similarities/differences between the two studies, we aimed to compare the active treatment results of the Greek cohorts between EFOS2 (n=301, all female) and ExFOS (n=416, 92.1% female). No statistical comparisons between studies were performed.
Results: Approximately 80% of patients in both cohorts were on treatment one month before maximum treatment period. Lumbar T-score (mean+SD) increased from −3.46±0.67 (n=175) at baseline to −2.54±0.74 (n=120) at study end in EFOS and from -3.39±0.73 (n=263) to −2.36±0.63 (n=78) in ExFOS. QoL and BP parameters had similar improvements, as shown by examples depicted below:
| Baseline | 3 m | 6 m | 12 m | 18 m | 24 m | |
| BP (in previous month) | ||||||
| ExFOS | 86.2% | 79.3% | 72.2% | 65.6% | 59.2% | 42.2% |
| EFOS | 93.2% | 84.6% | 77.8% | 66.4% | 64.2% | |
| BP frequency (every/almost every day) | ||||||
| ExFOS | 43.8% | 12.4% | 6.6% | 4.3% | 4.7% | 0% |
| EFOS | 39.9% | 7.5% | 3.9% | 2.5% | 2.2% | |
| BP severity (moderate/severe) | ||||||
| ExFOS | 76.2% | 50.4% | 32.8% | 20.9% | 22.2% | 18.6% |
| EFOS | 89.9% | 69.4% | 50.7% | 42.4% | 32.4% | |
| EQ-5D Mobility (some/extreme problems) | ||||||
| ExFOS | 57.9% | 38.9% | 29.9% | 22.5% | 17.7% | 16.2% |
| EFOS | 62.3% | 36.7% | 24.0% | 18.3% | 14.8% | |
| EQ-5D VAS | ||||||
| ExFOS | 57 | 66 | 71 | 75 | 77 | 83 |
| EFOS | 54 | 64 | 69 | 74 | 80 | |
Conclusions: Two similarly designed studies, in comparable Hellenic populations, yielded similar results that should be interpreted in the context of observational studies.
References: 1BMC Musculoskelet Disord. 2015;16:136.
2J Osteoporos. 2011;2011:510398.
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