TY - JOUR
T1 - Fracture Rate, Quality of Life and Back Pain in Patients with Osteoporosis Treated with Teriparatide
T2 - 24-Month Results from the Extended Forsteo Observational Study (ExFOS)
AU - Langdahl, Bente L.
AU - Ljunggren, Östen
AU - Benhamou, Claude Laurent
AU - Marin, Fernando
AU - Kapetanos, George
AU - Kocjan, Tomaz
AU - Lespessailles, Eric
AU - Napoli, Nicola
AU - Nikolic, Tatjana
AU - Petto, Helmut
AU - Moll, Thomas
AU - Lindh, Erik
PY - 2016/4/30
Y1 - 2016/4/30
N2 - 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.
AB - 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.
KW - Back pain
KW - Fractures
KW - Observational study
KW - Osteoporosis
KW - Quality of life
KW - Teriparatide
UR - http://www.scopus.com/inward/record.url?scp=84965009538&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84965009538&partnerID=8YFLogxK
U2 - 10.1007/s00223-016-0143-5
DO - 10.1007/s00223-016-0143-5
M3 - Article
AN - SCOPUS:84965009538
SP - 1
EP - 13
JO - Calcified Tissue International
JF - Calcified Tissue International
SN - 0171-967X
ER -