Effective osteoporosis treatment with teriparatide is associated with enhanced quality of life in postmenopausal women with osteoporosis: the European Forsteo Observational Study

Abstract

BackgroundTo describe changes in health-related quality of life (HRQoL) of postmenopausal women with osteoporosis treated with teriparatide for up to 18 months and followed-up for a further 18 months, and to assess the influence of recent prior and incident fractures.MethodsThe European Forsteo Observational Study (EFOS) is an observational, prospective, multinational study measuring HRQoL using the EQ-5D. The primary objective was to assess changes in HRQoL during 36 months in the whole study population. A secondary post-hoc analysis examined fracture impact on HRQoL in four subgroups classified based on recent prior fracture 12 months before baseline and incident clinical fractures during the study. Changes from baseline were analysed using a repeated measures model.ResultsOf the 1581 patients, 48.4% had a recent prior fracture and 15.6% of these patients had an incident fracture during follow-up. 10.9% of the 816 patients with no recent prior fracture had an incident fracture. Baseline mean EQ-VAS scores were similar across the subgroups. In the total study cohort (n = 1581), HRQoL (EQ-VAS and EQ-5D index scores) improved significantly from baseline to 18 months and this improvement was maintained over the 18-month post-teriparatide period. Improvements were seen across all five EQ-5D domains during teriparatide treatment that were maintained after teriparatide was discontinued. Subjects with incident clinical fractures had significantly less improvement in EQ-VAS than those without incident fractures. Recent prior fracture did not influence the change in EQ-VAS during treatment.ConclusionsEFOS is the first longitudinal study in women with severe postmenopausal osteoporosis in the real world setting to show a substantial improvement in HRQoL during teriparatide treatment that was sustained during subsequent treatment with other medications. The increase in HRQoL was lower in the subgroups with incident fracture but was not influenced by recent prior fracture. The results should be interpreted in the context of the design of an observational study.

Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)

“…However, the relationship between osteoporosis, fracture, back pain and HRQoL is not yet fully understood 35 . Improvements in HRQoL have been reported during treatment with teriparatide 19,33,36,37 , but the effect of teriparatide treatment on HRQoL across the now broader range of osteoporotic patients taking this medication for a longer period of time requires investigation. The longitudinal data from ExFOS should be useful in this context.…”

Efficacy and safety of currently marketed anti-osteoporosis medications

“…An improvement in HRQoL and, possibly, an early and significant reduction in back pain were also observed, which lasted for at least 18 months after TPD discontinuation when patients were taking other OP medication. The results should be interpreted in the context of an uncontrolled observational study [145,146].…”

Impacto del tratamiento con teriparatida en la calidad de vida de las personas con osteoporosis

“…En este primer trabajo en España sobre el efecto de la TPTD en los pacientes osteoporóticos, se muestra una reducción importante del dolor y una mejoría de la calidad de vida, así como una reducción también del número de fracturas, al igual que han demostrado los estudios realizados en otros países de Europa 5,6,10,21,23,24 , EE.UU 18,20 y Japón 13 . El porcentaje de pacientes que experimentaron mejora de la calidad de vida (65%) fue ligeramente inferior que los que obtuvieron mejora del dolor (80%), debido a que se trata de pacientes con edad avanzada y la TS incluye además del dolor otras dimensiones.…”

“…En lo que respecta al riesgo de fracturas tras la administración de la TPTD, sí se pudo comprobar una reducción del número, como ocurre en otros trabajos previos 5,6,10,20,21,23,24 , superior al 50%, (30 a 12 pacientes con fracturas) (tabla 1) y mayoritariamente vertebrales. Así, en un estudio 20 se redujo el riesgo en todo tipo de fracturas (vertebrales y no vertebrales), en otro 21 se demostró la reducción del riesgo de fracturas vertebrales, en 217 pacientes frente a 106 con tratamiento estándar (bifosfonatos), a lo largo de 5 años.…”

“…Se consideraron los valores de 0-3 como dolor leve, de 3-6 dolor moderado y de 7-10 dolor fuerte, registrándose los de cada uno de los pacientes en las fases previa y posterior a la toma del fármaco. Para la medición de la calidad de vida relacionada con la salud (CVRS) se utilizó el cuestionario europeo EQ-5D (anteriormente EuroQol), ampliamente utilizado en estudios sobre TPTD 5,6,10,23,24 por su sencillez y rapidez para la obtención de datos, así como por su utilidad en la asignación de recursos sanitarios.…”