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1. The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment

Author

Window, Trova@UniTO(opens in a. new, Export, Download | Add to List | More,, Rheumatology, Clinical, Experimental, Volume 34, Issue 2, The Italian observational study on severe osteoporosis: 24 month results on incidence of fractures, adherence to treatment Idolazzi, L. Abb, Maugeri, D. B, Monti, S. C, Massarotti, M. D, Osella, G. E, Barbagallo, M. F, Del Fiacco, R. G, Silvestri, S. G, Adami, S. H, Altomonte, L. I, Bardoscia, A. J, Bertoldo, F. K, Bevilacqua, M. L, Bianchi, G. M, Brancati, A. N, Cagnoni, C. O, Cantatore, F. P. P, Capone, A. Q, Costanzo, G. R, D'Avola, G. S, De Giorgi, G. T, Di Matteo, L. U, Di Munno, O. V, Filipponi, P. W, Frisina, N. X, Fusco, A. Y, Giannini, S. Z, Guiducci, S. Aa, Iolascon, G. Ab, Isaia, Giovanni Carlo, Lombardi, G. Ad, Malavolta, N. Ae, Marcocci, C. Af, Migliaccio, S. Ag, Migliore, A. Ah, Muratore, M. Ai, Nardi, A. Aj, Ortolani, S. Ak, Pasquali, R. Al, Petto, H. Am, Pietrogrande, L. An, Pola, E. Ao, Previti, B. Ap, Resmini, G. Aq, Rubinacci, A. Ar, Russo, E. As, Scillitani, A. At, Silveri, F. Au, Leali, P. T. Av, Trotta, F. Aw, Ulivieri, M. Ax, Verdoia, C. Ay, Versace, F. Az, Vinicola, V. Ba, Idolazzi, Luca, Maugeri, Domenico, Monti, Salvatore, Massarotti, Marco, Osella, Giangiacomo, Barbagallo, Mario, Del Fiacco, Romano, Silvestri, Sandra, Adami, S, Altomonte, L, Barbagallo, M, Bardoscia, A, delle Murge, C, Bertoldo, F, Bevilacqua, M, Bianchi, G, Brancati, A, Cagnoni, C, Cantatore, Fp, Capone, A, DI COSTANZO, Gennaro, D'Avola, G, De Giorgi, G, Di Matteo, L, Di Munno, O, Filipponi, P, Frisina, N, Fusco, A, Giannini, S, Guiducci, S, Iolascon, G, Isaia, G, Lombardi, G, Malavolta, N, Marcocci, C, Migliaccio, S, Migliore, A, Muratore, M, Nardi, A, Ortolani, S, Osella, G, Pasquali, R, Petto, H, Pietrogrande, L, Pola, E, Previti, B, Resmini, G, Rubinacci, A, Russo, Pina Elvira, Scillitani, A, Silveri, F, Leali, Pt, Trotta, F, Ulivieri, M, Verdoia, C, Versace, F, and Vinicola, V.

Subjects
Aged, 80 and over, Male, Spinal fracture, Incidence, Osteoporosi, Middle Aged, Parathyroid hormone, Spine, Medication Adherence, Fracture, Observational study, Osteoporosis therapy, Teriparatide, 80 and over, Settore MED/33 - Malattie Apparato Locomotore, Humans, Osteoporosis, Female, Prospective Studies, Aged, Osteoporotic Fractures
Abstract

Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study. Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

Published
2016

2. Baseline characteristics of the population enrolled in the Italian Observational Study on Severe Osteoporosis (ISSO)

Author

Adami S, Maugeri D, Toscano V, Monti S, Vottari S, Topa G, Malavolta N, Buffa A, Brancati A, Massarotti M, Osella G, Iolascon G, Cagnoni C, Camozzi V, Verdoia C, Corradini C, Nardi A, Ulivieri FM, Resmini G, Isaia G, Bevilacqua M, Ortolani S, Pietrogrande L, Rubinacci A, Giannini S, Lo Cascio V, Lacorte R, Massari L, Marcocci C, Di Munno O, Matucci-Cerinic M, Bianchi G, Filipponi P, Mannarino E, Migliaccio S, Spera G, Fornari R, Migliore A, Pola E, Costanzo G, De Marinis L, Di Matteo L, Lombardi G, Altomonte L, Silveri F, Cantatore FP, Scillitani A, Muratore M, Russo E, Salomone S, Barbagallo M, Previti B, Velluti C, Tranquilli Leali P, De Giorgi G, Vinicola V, Vedova D, Frisina N, Stisi S, Gallo A, Bardoscia A, Adami, S, Maugeri, D, Toscano, V, Monti, S, Vottari, S, Topa, G, Malavolta, N, Buffa, A, Brancati, A, Massarotti, M, Osella, G, Iolascon, G, Cagnoni, C, Camozzi, V, Verdoia, C, Corradini, C, Nardi, A, Ulivieri, Fm, Resmini, G, Isaia, G, Bevilacqua, M, Ortolani, S, Pietrogrande, L, Rubinacci, A, Giannini, S, Lo Cascio, V, Lacorte, R, Massari, L, Marcocci, C, Di Munno, O, Matucci-Cerinic, M, Bianchi, G, Filipponi, P, Mannarino, E, Migliaccio, S, Spera, G, Fornari, R, Migliore, A, Pola, E, Costanzo, G, De Marinis, L, Di Matteo, L, Lombardi, G, Altomonte, L, Silveri, F, Cantatore, Fp, Scillitani, A, Muratore, M, Russo, E, Salomone, S, Barbagallo, M, Previti, B, Velluti, C, Tranquilli Leali, P, De Giorgi, G, Vinicola, V, Vedova, D, Frisina, N, Stisi, S, Gallo, A, and Bardoscia, A

Abstract

OBJECTIVES: Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation. METHODS: Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, bone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS. RESULTS: Most patients were elderly women (90.5%), mean age±SD was 72.9±8.8 years. Nearly all (91.3%) had experienced ≥ 1 vertebral fracture (mean±SD, 3.6±2.2 per patient), 37.5% had ≥ 1 non-vertebral fracture (mean±SD, 1.4±0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58±0.25 and VAS score 49.2±23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p

Published
2011

3. Baseline charateristics of the population enrolled in the Italian Observational Study on Severe Osteoporosis (ISSO)

Author

Adami, S, Maugeri, D, Toscano, V, Topa, G, Carminiti, M, Brancati, A, Massarotti, M, Osella, G, Malavolta, N, Iolascon, G, Cagnoni, C, Camozzi, V, Corradini, C, Nardi, A, Migliaccio, S, Ulivieri, F. M, Resmini, G, Valle, D, Tauchmanovà, L, Silvestri, S, Monti, S, Vottari, S, Buffa, A, Verdoia, C, Ulivieri, Fm, Isaia, G, Bevilacqua, M, Ortolani, S, Pietrogrande, L, Rubinacci, A, Giannini, Sandro, Lo Cascio, V, Lacorte, R, Massari, L, Marcocci, C, Di Munno, O, Matucci Cerinic, M, Bianchi, G, Filipponi, P, Mannarino, E, Spera, G, Fornari, R, Migliore, A, Pola, E, Costanzo, G, De Marinis, L, Di Matteo, L, Lombardi, G, Altomonte, L, Silveri, F, Cantatore, Fp, Scillitani, A, Muratore, M, Russo, E, Salomone, S, Barbagallo, M, Previti, B, Velluti, C, Tranquilli Leali, P, De Giorgi, G, Vinicola, V, Vedova, D, Frisina, N, Stisi, S, Gallo, A, Bardoscia, A., Adami, S, Maugeri, D, Toscano, V, Topa, G, Caminiti, M, Brancati, A, Massarotti, M, Osella, G, Malavolta, N, Iolascon, Giovanni, Cagnoni, C, Camozzi, V, Corradini, C, Nardi, A, Migliaccio, S, Ulivieri, Fm, Resmini, G, Valle, D, Tauchmanova, L, and Silvestri, S.

Subjects
Male, Severity of Illness Index, Cohort Studies, Fractures, Bone, fractures, osteoporosis, treatment, quality of life, observational study, back pain, risk factors, Risk Factors, Teriparatide, 80 and over, severe osteoporosis, Humans, Longitudinal Studies, Prospective Studies, Bone, Aged, Retrospective Studies, Aged, 80 and over, Bone Density Conservation Agents, Incidence, Data Collection, Middle Aged, Italy, Back Pain, Female, Osteoporosis, Quality of Life, Spinal Fractures, Fractures
Abstract

Objective Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation. Methods Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, hone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS. Results Most patients were elderly women (90.5%), mean age +/- SD was 72.9 +/- 8.8 years. Nearly all (91.3%) had experienced >= 1 vertebral fracture (mean +/- SD, 3.6 +/- 2.2 per patient), 37.5% had >= 1 non-vertebral fracture (mean +/- SD, 1.4 +/- 0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58 +/- 0.25 and VAS score 49.2 +/- 23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p

Published
2011

4. The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment

Author

Idolazzi, L., Maugeri, D., Monti, S., Massarotti, M., Osella, G., Barbagallo, M., Del Fiacco, R., Silvestri, S., Adami, S., Altomonte, L., Bardoscia, A., Bertoldo, F., Bevilacqua, M., Bianchi, G., Brancati, A., Cagnoni, C., Cantatore, F. P., Capone, A., Costanzo, G., D Avola, G., Giorgi, G., Di Matteo, L., Di Munno, O., Filipponi, P., Frisina, N., Fusco, A., Giannini, S., Guiducci, S., Iolascon, G., Isaia, G., Lombardi, G., Malavolta, N., Marcocci, C., Migliaccio, S., Migliore, A., Muratore, M., Nardi, A., Ortolani, S., Pasquali, R., Petto, H., Pietrogrande, L., Pola, E., Previti, B., Resmini, G., Alessandro Rubinacci, Russo, E., Scillitani, A., Silveri, F., Leali, P. T., Trotta, F., Ulivieri, M., Verdoia, C., Versace, F., Vinicola, V., Idolazzi, Luca, Maugeri, Domenico, Monti, Salvatore, Massarotti, Marco, Osella, Giangiacomo, Barbagallo, Mario, Del Fiacco, Romano, Silvestri, Sandra, Adami, Silvano, Altomonte, Lorenzo, Bardoscia, Alfredo, Bertoldo, Francesco, Bevilacqua, Maurizio, Bianchi, Gerolamo, Brancati, Annamaria, Cagnoni, Carlo, Cantatore, Francesco Paolo, Capone, Antonio, Costanzo, Giuseppe, D'Avola, Giovanni, De Giorgi, Giuseppe, Di Matteo, Luigi, Di Munno, Ombretta, Filipponi, Paolo, Frisina, Nicola, Fusco, Alessandra, Giannini, Sandro, Guiducci, Serena, Iolascon, Giovanni, Isaia, Giancarlo, Lombardi, Gaetano, Malavolta, Nazzarena, Marcocci, Claudio, Migliaccio, Silvia, Migliore, Alberto, Muratore, Maurizio, Nardi, Alfredo, Ortolani, Sergio, Pasquali, Renato, Petto, Helmut, Pietrogrande, Luca, Pola, Enrico, Previti, Baldassarre, Resmini, Giuseppina, Rubinacci, Alessandro, Russo, Enzo, Scillitani, Alfredo, Silveri, Ferdinando, Leali, Paolo Tranquilli, Trotta, Francesco, Ulivieri, Massimo, Verdoia, Cesare, Versace, Francesco, and Vinicola, Vincenzo

Subjects
Spinal fracture, Fracture, Rheumatology, Observational study, Osteoporosis therapy, Teriparatide, Immunology, Osteoporosi, Immunology and Allergy, Parathyroid hormone, Spine
Abstract

Objective To estimate the proportion of patients with very severe osteoporosis (those covered by the reimbursement criteria of the Italian National Health Service) experiencing new vertebral and non-vertebral fragility fractures in the first 24 months of a new anti-osteoporosis treatment. Methods Prospective observational study in men and post-menopausal women (aged > 21 years) initiating anti-osteoporosis treatment for very severe osteoporosis. Eligibility was based on teriparatide (TPD) reimbursement criteria in Italy: Incident of vertebral or hip fracture during anti-resorptive treatment (minimum 1 year), or at least three prevalent severe vertebral fractures, or two prevalent severe vertebral fractures and a historical proximal hip fracture. Incidence of new clinical vertebral and non-vertebral fractures was documented by original x-rays and/or radiological reports, and a post-hoc analysis compared data from the TPD monotherapy population versus the total treated group. Results Overall, 767 patients (mean age 72.8 years, 90.7% women) were enrolled in the study, of whom 628, 538, 419 and 424 attended visits at 6, 12, 18 and 24 months, respectively. The most commonly prescribed therapy was TPD (single-agent; 64.5%), then bisphosphonates and other anti-resorptives (33.3%). A combination of different oral treatments was given to 22.5% of the patients. Overall treatment adherence at 24 months was 65.7%. In a post-hoc analysis, the overall incidence of new clinical vertebral and non-vertebral fractures in the total treated population was, respectively, 4.7% and 2.3% in the first 6 months; 1.8% and 1.6% in the 6-12 month period; 2.9% and 1.4% in the 12-18 month period; and 2.2% and 1.0% in the 18-24 month period. Conclusion In patients with very severe osteoporosis, the risk of new vertebral and non-vertebral fractures declined after the first 6 months and remained low throughout the study.

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