Abstract
ObjectivesThe European Forsteo Observational Study assessed the clinical fracture incidence, back pain, quality of life (QoL), and treatment persistence amongst post-menopausal women, who were prescribed teriparatide in routine care in eight European countries. We present the results for France, with health-insurance reimbursement criteria channel teriparatide to women with severe disease and limit treatment to 18months. MethodsA representative sample of women initiating teriparatide in France was followed in routine care for 36months. We described patients’ characteristics at baseline and persistence to teriparatide (Kaplan–Meier analysis), fracture incidence, back pain, and QoL (EQ-5D) at baseline, 18 and 36months follow-up (last-observation-carried-forward (LOCF) and mixed-models-for-repeated-measures (MMRM). ResultsOne hundred and sixteen rheumatologists included 309 patients, of whom 290 (93.9%) had at least one follow-up visit. Women's mean age (standard deviation) was 74.5years (7.4) and 296 (95.8%) had greater or equal to two vertebral fractures prior to teriparatide initiation. Clinical fracture incidence, mainly vertebral fractures, decreased around 6months after teriparatide initiation, and was sustained at 36months (P=0.013) when most patients were treated by anti-resorptives. Back pain and EQ-5D measures improved significantly at 18 and 36months (P<0.0001) in the LOCF analyses but did not improve in the EQ-5D VAS measure after covariate adjustment in the MMRM model. Median treatment duration was 17.4months. ConclusionFrench women initiating teriparatide in routine care had severe osteoporosis and showed good treatment persistence, consistent with France's insurance reimbursement criteria. Improvements in fracture risk and back pain began soon after treatment and was maintained at 36months follow-up.
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