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)

• Published in: Calcified tissue international Vol. 99; no. 3; pp. 259 - 271
• Main Authors: Langdahl, Bente L., Ljunggren, Östen, Benhamou, Claude-Laurent, Marin, Fernando, Kapetanos, George, Kocjan, Tomaz, Lespessailles, Eric, Napoli, Nicola, Nikolic, Tatjana, Petto, Helmut, Moll, Thomas, Lindh, Erik
• Format: Journal Article
• Language: English
• Published: New York Springer US 01-09-2016; Springer Nature B.V; Springer Verlag
• Subjects: Aged; Aged, 80 and over; Back pain; Back Pain - complications; Biochemistry; Biomedical and Life Sciences; Bone density; Bone Density Conservation Agents - therapeutic use; Cell Biology; Endocrinology; Female; Fractures; Fractures, Bone - complications; Fractures, Bone - drug therapy; Glucocorticoids - therapeutic use; Human health and pathology; Humans; Life Sciences; Male; Middle Aged; Observational study; Original Research; Orthopedics; Osteoporosis; Osteoporosis - complications; Osteoporosis - drug therapy; Pain Measurement - methods; Prospective Studies; Quality of Life; Rhumatology and musculoskeletal system; Teriparatide; Teriparatide - therapeutic use; Osteoporosis; Observational study; Back pain; Fractures; Teriparatide; Quality of life
• ISSN: 0171-967X; 1432-0827; 1432-0827
• DOI: 10.1007/s00223-016-0143-5

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.