Background The ISSO was an Italian, 24-month, observational, prospective study that evaluated the effectiveness of anti-osteoporotic treatments available in normal clinical practice for severe multi-fractured osteoporotic patients defined according to reimbursement criteria set out by the Italian Health National Service (Note 79, second part).
Objectives The primary objective of the study was to estimate the proportion of patients experiencing one or more new clinical vertebral and non-vertebral fragility fractures in the first 24 months from the initiation of anti-osteoporosis medication. The evaluation of back pain and Health-Related Quality of Life (HRQOL) at 18 and 24 months were important secondary endpoints of the study and results are herein presented.
Methods Back pain was evaluated by using a 0-10 visual analogue scale ([VAS]; 0 = no pain, 10 = worst possible pain), whereas the HRQOL was evaluated by using the European Quality of Life 5-Dimensions questionnaire (EQ-5D), which includes 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and with a 0-100 mm VAS (0 = worst imaginable health state, 100 = best imaginable health state).
Results Of the 769 patients (mean age ± SD 72.8±8.8 years; 689 [90.7%] women) enrolled between April 2008 and February 2009, 663 (87.2%) started a therapy and 438 (57.6%) completed the 24 months of observation. Teriparatide (572/663 patients, 86.3%) was the drug most commonly used during the study: 420/663 (63.3%) patients received only teriparatide (OT), 38/663 (5.7%) only bisphosphonates, 19/663 (2.9%) only parathyroid hormone, and 18/663 (2.7%) only strontium ranelate, while 168/663 patients (25.3%) took more than one drug. The rate of patients with back pain decreased from baseline to 18 and 24 months both in the total population (TP) (94.1%, 79.5% and 76.2%, respectively) and in those treated with OT (95.0%, 77.1% and 75.9%). The mean decreases in pain VAS from baseline to 18 and 24 months were -1.93 (95% CI: -2.21 to -1.65) and -2.05 (95% CI: -2.37 to -1.73) in TP, and were -2.31 (95% CI: -2.65 to -1.97) and -2.64 (95% CI: -3.04 to -2.23) in OT, respectively. The mean changes in EQ-5D score from baseline to 18 and 24 months were 0.125 (95% CI: 0.103 to 0.148) and 0.116 (95% CI: 0.093 to 0.138) in TP, and were 0.138 (95% CI: 0.108 to 0.167) and 0.121 (95% CI: 0.093 to 0.149) in OT, respectively. Changes in EQ-5D VAS were consistent with those of score.
Conclusions The results at 18 and 24 months of the ISSO study show that the prescribed treatment was associated with improvements in back pain and HRQOL, which were sustained up to the end of the 24-month observational period. Patients treated with teriparatide as monotherapy improved at least as markedly as did the TP.
Disclosure of Interest F. Bertoldo: None Declared, O. Di Munno: None Declared, L. Pietrogrande: None Declared, R. Del Fiacco Employee of: Eli Lilly Italy, H. Petto Employee of: Eli Lilly austria, P. Marchi Employee of: Eli Lilly Italy, S. Silvestri Shareholder of: Eli Lilly italy (minority shareholder), Employee of: Eli Lilly Italy