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Persistence with denosumab therapy in women affected by osteoporosis with fragility fractures: a multicenter observational real practice study in Italy

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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.

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Abbreviations

BPs:

Bisphosphonates

PMO:

Post-menopausal osteoporosis

RCTs:

Randomized clinical trials

BMD:

Bone mineral density

HRQoL:

Health related quality of life

FN:

Femoral neck

SD:

Standard deviations

LS:

Lumbar spine

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Author information

Author notes

  1. E. A. Greco and G. Iolascon contributed equally to this work.

Authors and Affiliations

  1. Section of Health Sciences, Department of Movement, Human and Health Sciences, University “Foro Italico”, Piazza Lauro de Bosis, 6, 00135, Rome, Italy

    S. Migliaccio

  2. Section of Medical Pathophysiology, Endocrinology and Nutrition, Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy

    D. Francomano, E. Romagnoli, C. Marocco, R. Fornari, A. Lenzi & E. A. Greco

  3. Section of Orthopaedic and Traumatology, Center of Osteoporosis and Skeletal Metabolic Diseases, ASST-Bergamo Ovest, Treviglio-Caravaggio, Italy

    G. Resmini

  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

    A. Buffa, S. Corvaglia & N. Malavolta

  5. Department of Medical and Surgical Specialties and Dentistry, University of Campania “Luigi Vanvitelli”, Via de Crecchio 4, 80138, Naples, Italy

    G. Di Pietro, A. Moretti, A. de Sire & G. Iolascon

  6. Department of Physical and Mental Health and Preventive Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy

    F. Gimigliano

Authors
  1. S. Migliaccio
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  2. D. Francomano
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  3. E. Romagnoli
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  4. C. Marocco
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  5. R. Fornari
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  6. G. Resmini
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  7. A. Buffa
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  8. G. Di Pietro
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  9. S. Corvaglia
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  10. F. Gimigliano
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  11. A. Moretti
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  12. A. de Sire
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  13. N. Malavolta
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  14. A. Lenzi
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  15. E. A. Greco
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  16. G. Iolascon
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Corresponding authors

Correspondence to S. Migliaccio or G. Iolascon.

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Conflict of interest

All authors declare no conflict of interest.

Ethical approval

The study received the approval of the Internal Review Board of each Institution involved.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Migliaccio, S., Francomano, D., Romagnoli, E. et al. Persistence with denosumab therapy in women affected by osteoporosis with fragility fractures: a multicenter observational real practice study in Italy. J Endocrinol Invest 40, 1321–1326 (2017). https://doi.org/10.1007/s40618-017-0701-3

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  • DOI: https://doi.org/10.1007/s40618-017-0701-3

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