S Migliaccio1, D Francomano2, E Romagnoli2, C Marocco2, R Fornari2, G Resmini3, A Buffa4, G Di Pietro5, S Corvaglia4, F Gimigliano6, A Moretti5, A de Sire5, N Malavolta4, A Lenzi2, E A Greco2, G Iolascon7. 1. Section of Health Sciences, Department of Movement, Human and Health Sciences, University "Foro Italico", Piazza Lauro de Bosis, 6, 00135, Rome, Italy. silvia.migliaccio@uniroma4.it. 2. Section of Medical Pathophysiology, Endocrinology and Nutrition, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy. 3. Section of Orthopaedic and Traumatology, Center of Osteoporosis and Skeletal Metabolic Diseases, ASST-Bergamo Ovest, Treviglio-Caravaggio, Italy. 4. Departmental Program: Rheumatic, Connective and Bone Metabolic Diseases Management Bologna, Department of Medical and Surgical Sciences, St Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. 5. Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", Via de Crecchio 4, 80138, Naples, Italy. 6. Department of Physical and Mental Health and Preventive Medicine, University of Campania "Luigi Vanvitelli", Naples, Italy. 7. Department of Medical and Surgical Specialties and Dentistry, University of Campania "Luigi Vanvitelli", Via de Crecchio 4, 80138, Naples, Italy. giovanni.iolascon@gmail.com.
Abstract
BACKGROUND: Persistence is commonly considered a key factor for the successful management of osteoporosis and fragility fractures. Denosumab is the first biologic agent developed for the treatment of osteoporosis with satisfying data regarding the persistence with this therapy. AIM: The purpose of this multicenter observational real practice study was to evaluate the persistence with denosumab treatment in post-menopausal women affected by osteoporosis. MATERIAL/SUBJECTS AND METHODS: Women were recruited in four specialized centers for the management of osteoporosis in North, Center and South of Italy. We included women with a diagnosis of post-menopausal osteoporosis, aged >50 years, able to obtain a prescription according to the Italian reimbursement criteria in force during the study period for anti-osteoporotic pharmacological treatment. They initiated a treatment with subcutaneous denosumab (Prolia®) 60 mg/every 6 months between November 2011 and May 2016. Women who had received aromatase inhibitors were excluded. Patients were assessed at baseline and every 6 months for all treatment length. Persistence data were evaluated for a total of 36 months. RESULTS: Eight hundred seventy women were enrolled; mean aged 70 years, with a mean body mass index of 24.8 ± 4.1 kg/m2. At the Dual-energy X-ray absorptiometry assessment, the mean lumbar spine T-score was -2.76 ± 1.14 standard deviations (SD) and the mean femoral neck T-score was -2.49 ± 0.80 SD. During the study, the total persistence was 91.4%. Total dropouts were 75 (8.6%), higher within the initial 6-month period of treatment. CONCLUSIONS: Persistence to denosumab treatment in our observational real practice study was very high. These results suggest that factors such as frequency of visits, pharmacological schedule, and opportunity to call the doctor might play an important role in the persistence and adherence to treatment to obtain maximum therapeutic effect and avoid further fragility fractures.
BACKGROUND: Persistence is commonly considered a key factor for the successful management of osteoporosis and fragility fractures. Denosumab is the first biologic agent developed for the treatment of osteoporosis with satisfying data regarding the persistence with this therapy. AIM: The purpose of this multicenter observational real practice study was to evaluate the persistence with denosumab treatment in post-menopausal women affected by osteoporosis. MATERIAL/SUBJECTS AND METHODS: Women were recruited in four specialized centers for the management of osteoporosis in North, Center and South of Italy. We included women with a diagnosis of post-menopausal osteoporosis, aged >50 years, able to obtain a prescription according to the Italian reimbursement criteria in force during the study period for anti-osteoporotic pharmacological treatment. They initiated a treatment with subcutaneous denosumab (Prolia®) 60 mg/every 6 months between November 2011 and May 2016. Women who had received aromatase inhibitors were excluded. Patients were assessed at baseline and every 6 months for all treatment length. Persistence data were evaluated for a total of 36 months. RESULTS: Eight hundred seventy women were enrolled; mean aged 70 years, with a mean body mass index of 24.8 ± 4.1 kg/m2. At the Dual-energy X-ray absorptiometry assessment, the mean lumbar spine T-score was -2.76 ± 1.14 standard deviations (SD) and the mean femoral neck T-score was -2.49 ± 0.80 SD. During the study, the total persistence was 91.4%. Total dropouts were 75 (8.6%), higher within the initial 6-month period of treatment. CONCLUSIONS: Persistence to denosumab treatment in our observational real practice study was very high. These results suggest that factors such as frequency of visits, pharmacological schedule, and opportunity to call the doctor might play an important role in the persistence and adherence to treatment to obtain maximum therapeutic effect and avoid further fragility fractures.
Authors: David L Kendler; Christian Roux; Claude Laurent Benhamou; Jacques P Brown; Michael Lillestol; Suresh Siddhanti; Hoi-Shen Man; Javier San Martin; Henry G Bone Journal: J Bone Miner Res Date: 2010-01 Impact factor: 6.741
Authors: Jacques P Brown; Richard L Prince; Chad Deal; Robert R Recker; Douglas P Kiel; Luiz H de Gregorio; Peyman Hadji; Lorenz C Hofbauer; Jose M Alvaro-Gracia; Huei Wang; Matthew Austin; Rachel B Wagman; Richard Newmark; Cesar Libanati; Javier San Martin; Henry G Bone Journal: J Bone Miner Res Date: 2009-01 Impact factor: 6.741
Authors: Robert A Yood; Srinivas Emani; John I Reed; Barbara Edelman Lewis; Mary Charpentier; Eva Lydick Journal: Osteoporos Int Date: 2003-09-19 Impact factor: 4.507
Authors: Joyce A Cramer; Anuja Roy; Anita Burrell; Carol J Fairchild; Mahesh J Fuldeore; Daniel A Ollendorf; Peter K Wong Journal: Value Health Date: 2008 Jan-Feb Impact factor: 5.725
Authors: Michael McClung; Steven T Harris; Paul D Miller; Douglas C Bauer; K Shawn Davison; Larry Dian; David A Hanley; David L Kendler; Chui Kin Yuen; E Michael Lewiecki Journal: Am J Med Date: 2012-11-20 Impact factor: 4.965
Authors: P Hadji; N Papaioannou; E Gielen; M Feudjo Tepie; E Zhang; I Frieling; P Geusens; P Makras; H Resch; G Möller; L Kalouche-Khalil; A Fahrleitner-Pammer Journal: Osteoporos Int Date: 2015-05-28 Impact factor: 4.507
Authors: E Cairoli; S Palmieri; G Goggi; L Roggero; M Arosio; I Chiodini; C Eller-Vainicher Journal: J Endocrinol Invest Date: 2018-01-16 Impact factor: 4.256
Authors: Olga Růžičková; Zdenko Killinger; Petr Kasalický; Lisa Hamilton; Roman Tyl; Soňa Tomková; Lama Kalouche-Khalil Journal: Adv Ther Date: 2018-09-06 Impact factor: 3.845
Authors: Chiara Marocco; Giovanna Zimatore; Edoardo Mocini; Rachele Fornari; Giovanni Iolascon; Maria Chiara Gallotta; Viviana Maria Bimonte; Carlo Baldari; Andrea Lenzi; Silvia Migliaccio Journal: Int J Environ Res Public Health Date: 2021-02-10 Impact factor: 3.390
Authors: Maria Rosa Iaquinta; Elisa Mazzoni; Ilaria Bononi; John Charles Rotondo; Chiara Mazziotta; Monica Montesi; Simone Sprio; Anna Tampieri; Mauro Tognon; Fernanda Martini Journal: Front Cell Dev Biol Date: 2019-11-12