Objective: To evaluate the effectiveness of denosumab in reducing back pain related disability and improving Health Related Quality of Life (HRQoL) in women with postmenopausal osteoporosis and vertebral fractures. Material and Methods:We included women aged ≥50 years with a diagnosis of postmenopausal osteoporosis that had already experienced at least one vertebral fragility fracture. They were treated with subcutaneous denosumab (60 mg/every 6 months) and a supplementation of calcium carbonate (500–1000 mg/day) and cholecalciferol (800 IU/day) for 1 year. We evaluated at the baseline (T0), after 6 months (T1), and after 12 months (T2) of treatment the following outcomes: back pain related disability, assessed by Spine Pain Index (SPI), and HRQoL, using the 12-Item Short Form Health Survey (SF-12), with Physical (PCS) and Mental Health Composite Scores (MCS) and the European Quality of Life - 5 Dimensions - 3 Levels (EuroQol-5D-3 L) index (EQ- 5D-3 L index) and the EuroQol-Visual analogue scale scores (EQ VAS). Results: We enrolled 140 women, mean aged 74.89 ±8.80 years, with a mean BMI of 26.13±3.93 kg/m2. Results are reported in Table 1. Table 1. Outcomemeasures at the baseline (T0), after 6months (T1), and after 1 year (T2) of subcutaneous denosumab therapy T0 T1 T2 P values SPI 58.49 ± 19.94 45.03 ± 21.97 40.38 ± 21.21 P <0.001* SF-12PCS 29.5 (24.6 – 34.1) 35.4 (29– 40.9) 35.7 (29.3 – 42.95) P <0.001** SF-12MCS 37.0 (29.55 – 44.72) 44.6 (35.5 – 53.85) 45.9 (36.92 – 55.17) P <0.001** EQ-5D-3 L index 0.60 (0.32 – 0.76) 0.69 (0.6 – 0.81) 0.69 (0.6 – 0.82 P <0.001** EQ VAS 4.67 ± 1.86 5.68 ± 1.50 6.20 ± 1.63 P <0.001* Continuous variables are expressed as means ± standards deviations. Categorical variables are expressed as median values (interquartile interval).* = Friedman Test; ** =ANOVA for repeated measures Conclusions: Our results demonstrated that denosumab is significantly effective in reducing back pain related disability and in improving HRQoL in women with vertebral osteoporotic fractures already after 6 months, and these findings are confirmed even at one year of treatment.

P270 DENOSUMAB REDUCES BACK PAIN RELATED DISABILITY AND IMPROVES HEALTH RELATED QUALITY OF LIFE IN WOMEN WITH VERTEBRAL FRAGILITY FRACTURES: A PROSPECTIVE COHORT STUDY

G. Iolascon;Moretti A;F. Gimigliano
2016

Abstract

Objective: To evaluate the effectiveness of denosumab in reducing back pain related disability and improving Health Related Quality of Life (HRQoL) in women with postmenopausal osteoporosis and vertebral fractures. Material and Methods:We included women aged ≥50 years with a diagnosis of postmenopausal osteoporosis that had already experienced at least one vertebral fragility fracture. They were treated with subcutaneous denosumab (60 mg/every 6 months) and a supplementation of calcium carbonate (500–1000 mg/day) and cholecalciferol (800 IU/day) for 1 year. We evaluated at the baseline (T0), after 6 months (T1), and after 12 months (T2) of treatment the following outcomes: back pain related disability, assessed by Spine Pain Index (SPI), and HRQoL, using the 12-Item Short Form Health Survey (SF-12), with Physical (PCS) and Mental Health Composite Scores (MCS) and the European Quality of Life - 5 Dimensions - 3 Levels (EuroQol-5D-3 L) index (EQ- 5D-3 L index) and the EuroQol-Visual analogue scale scores (EQ VAS). Results: We enrolled 140 women, mean aged 74.89 ±8.80 years, with a mean BMI of 26.13±3.93 kg/m2. Results are reported in Table 1. Table 1. Outcomemeasures at the baseline (T0), after 6months (T1), and after 1 year (T2) of subcutaneous denosumab therapy T0 T1 T2 P values SPI 58.49 ± 19.94 45.03 ± 21.97 40.38 ± 21.21 P <0.001* SF-12PCS 29.5 (24.6 – 34.1) 35.4 (29– 40.9) 35.7 (29.3 – 42.95) P <0.001** SF-12MCS 37.0 (29.55 – 44.72) 44.6 (35.5 – 53.85) 45.9 (36.92 – 55.17) P <0.001** EQ-5D-3 L index 0.60 (0.32 – 0.76) 0.69 (0.6 – 0.81) 0.69 (0.6 – 0.82 P <0.001** EQ VAS 4.67 ± 1.86 5.68 ± 1.50 6.20 ± 1.63 P <0.001* Continuous variables are expressed as means ± standards deviations. Categorical variables are expressed as median values (interquartile interval).* = Friedman Test; ** =ANOVA for repeated measures Conclusions: Our results demonstrated that denosumab is significantly effective in reducing back pain related disability and in improving HRQoL in women with vertebral osteoporotic fractures already after 6 months, and these findings are confirmed even at one year of treatment.
File in questo prodotto:
Non ci sono file associati a questo prodotto.

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11591/419734
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus ND
  • ???jsp.display-item.citation.isi??? ND
social impact