title: Fracture Rate, Quality of Life and Back Pain in Patients with Osteoporosis Treated with Teriparatide: 24-Month Results from the Extended Forsteo Observational Study (ExFOS).
abstract: We describe the pre-planned interim analysis of fracture outcomes, health-related quality of life (HRQoL) and back pain in patients with severe osteoporosis treated with teriparatide for up to 24 months in the Extended Forsteo (Forsteo(®) is a registered trade name of Eli Lilly and Company) Observational Study (ExFOS), a prospective, multinational, observational study. Data on incident clinical fractures, HRQoL (EQ-5D questionnaire) and back pain [100 mm visual analogue scale (VAS)] were collected. The number of patients with fractures was summarised in 6-month intervals and fracture rate over each 6-month period was assessed using logistic regression for repeated measures. Changes from baseline in EQ-5D and back pain VAS were analysed using mixed models for repeated measures. Of 1454 patients in the active treatment cohort, 90.6 % were female and 14.4 % were taking glucocorticoids. During teriparatide treatment (median duration 23.7 months), 103 patients (7.1 %) sustained a total of 122 incident clinical fractures (21 % vertebral, 79 % non-vertebral). A 49 % decrease in the odds of fractures and a 75 % decrease in the odds of clinical vertebral fractures were observed in the >18- to 24-month period versus the first 6-month period (both p < 0.05). EQ-5D scores and back pain VAS scores were significantly improved from baseline at each post-baseline observation during teriparatide treatment. In conclusion, patients with severe osteoporosis showed a significant reduction in the incident fracture rate during 24 months of teriparatide treatment in routine clinical practice, accompanied by a significant improvement in HRQoL and reduction in back pain. Results should be interpreted in the context of the non-controlled design of this observational study.
authors.affiliation: Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Tage Hansens Gade 2, 8000, Aarhus, Denmark. bente.langdahl@aarhus.rm.dk.
authors.forename: Bente L
authors.initials: BL
authors.lastname: Langdahl
authors.affiliation: Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
authors.forename: Östen
authors.initials: Ö
authors.lastname: Ljunggren
authors.affiliation: Orléans Hospital, Orléans, France.
authors.forename: Claude-Laurent
authors.initials: CL
authors.lastname: Benhamou
authors.affiliation: Eli Lilly and Company, Windlesham, Surrey, UK.
authors.forename: Fernando
authors.initials: F
authors.lastname: Marin
authors.affiliation: Papageorgiou General Hospital, Thessaloniki, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Kapetanos
authors.affiliation: University Medical Centre, Ljubljana, Slovenia.
authors.forename: Tomaz
authors.initials: T
authors.lastname: Kocjan
authors.affiliation: Orléans Hospital, Orléans, France.|EA-4708-I3MTO, University of Orléans, Orléans, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Lespessailles
authors.affiliation: University Campus Bio-Medico, Rome, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Napoli
authors.affiliation: University Hospital, Zagreb, Croatia.
authors.forename: Tatjana
authors.initials: T
authors.lastname: Nikolic
authors.affiliation: Eli Lilly and Company, Windlesham, Surrey, UK.
authors.forename: Helmut
authors.initials: H
authors.lastname: Petto
authors.affiliation: Eli Lilly and Company, Windlesham, Surrey, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Moll
authors.affiliation: Eli Lilly and Company, Windlesham, Surrey, UK.
authors.forename: Erik
authors.initials: E
authors.lastname: Lindh
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000150:complications*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D005260:Female; D050723:Fractures, Bone / Q000150:complications / Q000188:drug therapy*; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy*; D010147:Pain Measurement / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D019379:Teriparatide / Q000627:therapeutic use*
chemical_list: D050071:Bone Density Conservation Agents; D005938:Glucocorticoids; D019379:Teriparatide
keywords: Back pain; Fractures; Observational study; Osteoporosis; Quality of life; Teriparatide