The Italian observational study on severe osteoporosis (ISSO)

24-month results on incidence of fractures and adherence to treatment

Luca Idolazzi, D. Maugeri, S. Monti, Marco Sergio Massarotti, Giangiacomo Osella, Mario Barbagallo, Romano Del Fiacco, Sandra Silvestri, S. Adami, Lorenzo Altomonte, Alfredo Bardoscia, Francesco Bertoldo, Maurizio Bevilacqua, Gerolamo Bianchi, Anna Maria Brancati, Carlo Cagnoni, F. Cantatore, Antonio Capone, Giuseppe Costanzo, Giovanni D'Avola & 34 others Giuseppe De Giorgi, L. Di Matteo, Ombretta Di Munno, P. Filipponi, Nicola Frisina, Alessandra Fusco, Sandro Giannini, Serena Guiducci, Giovanni Iolascon, Giancarlo Isaia, Gaetano Lombardi, Nazzarena Malavolta, C. Marcocci, S. Migliaccio, A. Migliore, Maurizio Muratore, A. Nardi, Sergio Ortolani, Renato Pasquali, H. Petto, Luca Pietrogrande, Enrico Pola, Baldassarre Previti, G. Resmini, Alessandro Rubinacci, Enzo Russo, Alfredo Scillitani, Ferdinando Silveri, Paolo Tranquilli Leali, F. Trotta, Massimo Ulivieri, C. Verdoia, F. Versace, Vincenzo Vinicola

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)247-253
Number of pages7
JournalClinical and Experimental Rheumatology
Volume34
Issue number2
Publication statusPublished - Mar 1 2016

Fingerprint

Osteoporosis
Observational Studies
Teriparatide
Incidence
Hip Fractures
Therapeutics
Diphosphonates
National Health Programs
Italy
Population
X-Rays
Prospective Studies

Keywords

  • Fractures
  • Observational study
  • Osteoporosis
  • Osteoporosis therapy
  • Parathyroid hormone
  • Spinal fractures
  • Spine
  • Teriparatide

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy

Cite this

Idolazzi, L., Maugeri, D., Monti, S., Massarotti, M. S., Osella, G., Barbagallo, M., ... Vinicola, V. (2016). The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment. Clinical and Experimental Rheumatology, 34(2), 247-253.

The Italian observational study on severe osteoporosis (ISSO) : 24-month results on incidence of fractures and adherence to treatment. / Idolazzi, Luca; Maugeri, D.; Monti, S.; Massarotti, Marco Sergio; Osella, Giangiacomo; Barbagallo, Mario; Del Fiacco, Romano; Silvestri, Sandra; Adami, S.; Altomonte, Lorenzo; Bardoscia, Alfredo; Bertoldo, Francesco; Bevilacqua, Maurizio; Bianchi, Gerolamo; Brancati, Anna Maria; Cagnoni, Carlo; Cantatore, F.; Capone, Antonio; Costanzo, Giuseppe; D'Avola, Giovanni; De Giorgi, Giuseppe; Di Matteo, L.; Di Munno, Ombretta; Filipponi, P.; Frisina, Nicola; Fusco, Alessandra; Giannini, Sandro; Guiducci, Serena; Iolascon, Giovanni; Isaia, Giancarlo; Lombardi, Gaetano; Malavolta, Nazzarena; Marcocci, C.; Migliaccio, S.; Migliore, A.; Muratore, Maurizio; Nardi, A.; Ortolani, Sergio; Pasquali, Renato; Petto, H.; Pietrogrande, Luca; Pola, Enrico; Previti, Baldassarre; Resmini, G.; Rubinacci, Alessandro; Russo, Enzo; Scillitani, Alfredo; Silveri, Ferdinando; Leali, Paolo Tranquilli; Trotta, F.; Ulivieri, Massimo; Verdoia, C.; Versace, F.; Vinicola, Vincenzo.

In: Clinical and Experimental Rheumatology, Vol. 34, No. 2, 01.03.2016, p. 247-253.

Research output: Contribution to journalArticle

Idolazzi, L, Maugeri, D, Monti, S, Massarotti, MS, Osella, G, Barbagallo, M, Del Fiacco, R, Silvestri, S, Adami, S, Altomonte, L, Bardoscia, A, Bertoldo, F, Bevilacqua, M, Bianchi, G, Brancati, AM, Cagnoni, C, Cantatore, F, Capone, A, Costanzo, G, 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, Pasquali, R, Petto, H, Pietrogrande, L, Pola, E, Previti, B, Resmini, G, Rubinacci, A, Russo, E, Scillitani, A, Silveri, F, Leali, PT, Trotta, F, Ulivieri, M, Verdoia, C, Versace, F & Vinicola, V 2016, 'The Italian observational study on severe osteoporosis (ISSO): 24-month results on incidence of fractures and adherence to treatment', Clinical and Experimental Rheumatology, vol. 34, no. 2, pp. 247-253.
Idolazzi, Luca ; Maugeri, D. ; Monti, S. ; Massarotti, Marco Sergio ; Osella, Giangiacomo ; Barbagallo, Mario ; Del Fiacco, Romano ; Silvestri, Sandra ; Adami, S. ; Altomonte, Lorenzo ; Bardoscia, Alfredo ; Bertoldo, Francesco ; Bevilacqua, Maurizio ; Bianchi, Gerolamo ; Brancati, Anna Maria ; Cagnoni, Carlo ; Cantatore, F. ; Capone, Antonio ; Costanzo, Giuseppe ; D'Avola, Giovanni ; De Giorgi, Giuseppe ; Di Matteo, L. ; Di Munno, Ombretta ; Filipponi, P. ; Frisina, Nicola ; Fusco, Alessandra ; Giannini, Sandro ; Guiducci, Serena ; Iolascon, Giovanni ; Isaia, Giancarlo ; Lombardi, Gaetano ; Malavolta, Nazzarena ; Marcocci, C. ; Migliaccio, S. ; Migliore, A. ; Muratore, Maurizio ; Nardi, A. ; Ortolani, Sergio ; Pasquali, Renato ; Petto, H. ; Pietrogrande, Luca ; Pola, Enrico ; Previti, Baldassarre ; Resmini, G. ; Rubinacci, Alessandro ; Russo, Enzo ; Scillitani, Alfredo ; Silveri, Ferdinando ; Leali, Paolo Tranquilli ; Trotta, F. ; Ulivieri, Massimo ; Verdoia, C. ; Versace, F. ; Vinicola, Vincenzo. / The Italian observational study on severe osteoporosis (ISSO) : 24-month results on incidence of fractures and adherence to treatment. In: Clinical and Experimental Rheumatology. 2016 ; Vol. 34, No. 2. pp. 247-253.
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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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TY - JOUR

T1 - The Italian observational study on severe osteoporosis (ISSO)

T2 - 24-month results on incidence of fractures and adherence to treatment

AU - Idolazzi, Luca

AU - Maugeri, D.

AU - Monti, S.

AU - Massarotti, Marco Sergio

AU - Osella, Giangiacomo

AU - Barbagallo, Mario

AU - Del Fiacco, Romano

AU - Silvestri, Sandra

AU - Adami, S.

AU - Altomonte, Lorenzo

AU - Bardoscia, Alfredo

AU - Bertoldo, Francesco

AU - Bevilacqua, Maurizio

AU - Bianchi, Gerolamo

AU - Brancati, Anna Maria

AU - Cagnoni, Carlo

AU - Cantatore, F.

AU - Capone, Antonio

AU - Costanzo, Giuseppe

AU - D'Avola, Giovanni

AU - De Giorgi, Giuseppe

AU - Di Matteo, L.

AU - Di Munno, Ombretta

AU - Filipponi, P.

AU - Frisina, Nicola

AU - Fusco, Alessandra

AU - Giannini, Sandro

AU - Guiducci, Serena

AU - Iolascon, Giovanni

AU - Isaia, Giancarlo

AU - Lombardi, Gaetano

AU - Malavolta, Nazzarena

AU - Marcocci, C.

AU - Migliaccio, S.

AU - Migliore, A.

AU - Muratore, Maurizio

AU - Nardi, A.

AU - Ortolani, Sergio

AU - Pasquali, Renato

AU - Petto, H.

AU - Pietrogrande, Luca

AU - Pola, Enrico

AU - Previti, Baldassarre

AU - Resmini, G.

AU - Rubinacci, Alessandro

AU - Russo, Enzo

AU - Scillitani, Alfredo

AU - Silveri, Ferdinando

AU - Leali, Paolo Tranquilli

AU - Trotta, F.

AU - Ulivieri, Massimo

AU - Verdoia, C.

AU - Versace, F.

AU - Vinicola, Vincenzo

PY - 2016/3/1

Y1 - 2016/3/1

N2 - 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.

AB - 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.

KW - Fractures

KW - Observational study

KW - Osteoporosis

KW - Osteoporosis therapy

KW - Parathyroid hormone

KW - Spinal fractures

KW - Spine

KW - Teriparatide

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