Improvement in health status and quality of life in patients with osteoporosis treated with denosumab: results at a mean follow-up of six years

OBJECTIVE: The clinical efficacy and tolerability of denosumab in severe osteoporosis are well-known. However, the evaluation on general health and quality of life over time and compared to population norms is still lacking. We aimed at evaluating denosumab effectiveness in a real-world clinical sample with a 6-years average follow-up. PATIENTS AND METHODS: In this retrospective-matched study with prospective data collection, a total of 101 patients affected by severe osteoporosis and treated with denosumab between 2014 and 2020 were evaluated. All patients completed the self- perceived quality of life (36-Item Short Form - SF-36) survey and visual analogue scale (VAS) before and after treatment. RESULTS: Overall, 13 patients died of causes unrelated to the procedure, 12 stopped therapy with denosumab, and 30 did not participate in the follow-up; thus, 46 patients completed the study. There were 44 (95.7%) women and 93.4% of patients reported history of osteoporotic fractures. The mean follow-up was 59 +/- 17.8 months and the mean age at follow-up was 73.9 +/- 10.6 years. We found a significant improvement in bodily pain (baseline 53.8 +/- 33.4, follow-up 62.7 +/- 26.6; p=0.002) and in general health (baseline 35 +/- 25.4, follow-up 41.7 +/- 24.2; p= 0.002) over time. The bodily pain score at follow-up was similar to the mean of the age- matched healthy population (62.7 +/- 26.6 vs. 67.6 +/- 26, p= 0.374). The MCS-36 scores were higher than the normative values before treatment and at follow-up (51.6 +/- 9.8 vs. 45.8 +/- 9, p= 0.004 and 50.6 +/- 11.7 vs. 45.8 +/- 9, p= 0.030, respectively). The PCS-36 score at follow-up was comparable to the normative values (39.4 +/- 10.4 vs. 42.7 +/- 9, p= 0.107). CONCLUSIONS: Denosumab is effective to improve bone health and global mental and physical wellbeing, and quality of life over time.