ECTS2013 Poster Presentations Osteoporosis: treatment (64 abstracts)
Study description and baseline characteristics of the population enrolled in the extended forsteo® observational study (ExFOS)
Bente Langdahl 1 , Claude Benhamou 2 , Erik Lindh 3 , Joannes Dekker 4 , Giorgios Kapetanos 9 , Tomaz Kocjan 5 , Östen Ljunggren 6 , Nicola Napoli 7 , Helmut Petto 8 & Tatjana Nicolic 10
1Aarhus university Hospital, Aarhus, Denmark; 2Hôpital d’Orléans La Source, Orléans La Source, France; 3Eli Lilly Sweden AB, Solna, Sweden; 4Levanger Hospital, Levanger, Norway; 5University Medical Centre Ljubljana, Ljubljana, Slovenia; 6University Hospital Uppsala, Uppsala, Sweden; 7University Campus Bio-Medico di Roma, Rome, Italy; 8Eli Lilly research centre, Vienna, Austria; 9Papageorgiou General Hospital, Thessaloniki, Greece; 10Sestre Milosrdnice University Hospital Center, Zagreb, Croatia.
ExFOS is a multicenter, prospective, observational study to evaluate fracture outcomes, back pain, compliance and health-related quality of life in female and male patients with osteoporosis treated with teriparatide [rhPTH(1–34)] (Forsteo)for 18 to 24 months. Post-treatment follow-up will last for at least 18 months. Patients were enrolled in Croatia, Denmark, France, Greece, Italy, Norway, Slovenia, and Sweden. The study design was non-interventional and all consenting patients prescribed teriparatide in the course of normal clinical practice were eligible for enrolment.
Overall, 1607 patients with evaluable baseline characteristics were enrolled in the study. Of these, 1460 (90.9%) were female and 147 (9.1%) male. The mean (S.D) age was 70.3 (9.8) years and 85.8% of all patients had a history of fracture, with 64.7% of patients having had two or more fractures. The mean (S.D) number of prevalent fractures was 2.4 (1.9) and 90.8% of those were vertebral fractures. The mean (S.D) BMD T-scores were −3.0 (1.2), −2.4 (1.0) and −2.5 (0.9) for lumbar spine, total hip and femoral neck, respectively. Moreover, 16.7% of the cohort had a history of maternal hip fracture, 39.3% had experienced at least one fall during the 12 months before enrollment and 14.5% were current smokers. Only 11.4% of patients were osteoporosis treatment naïve and 15% were currently using glucocorticoids. The mean (S.D) visual analogue scale (VAS) score for back pain during the last month was 50.7 (26.9) and 62.1% of patients experienced daily or almost daily back pain. The mean (S.D) EQ-5D health state value (HSV) was 0.49 (0.36).
The baseline profile of the study cohort indicates that patients prescribed Forsteo in ExFOS are severely osteoporotic with increased risk of fractures and a reduced HRQoL despite previous pharmacotherapy for osteoporosis
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