open access
Osteoporosis treatment with denosumab in routine clinical practice in Poland
- Department of Geriatrics and Gerontology, School of Public Health, Medical Centre of Postgraduate Education, Warsaw, Poland
- Chair and Department of Rehabilitation and Orthopaedics, Medical University of Lublin, Lublin, Poland
- Specialist Outpatient Clinic Reumed, Lublin, Poland
- Interdisciplinary Academy of Practical Medicine, Warsaw, Poland
- Amgen Biotechnology, Warsaw, Poland
- Department of Endocrine Disorders and Bone Metabolism, Medical University of Lodz, Lodz, Poland
open access
Abstract
Introduction: The receptor activator for nuclear factor k B ligand (RANKL) inhibitor denosumab is approved for the treatment of osteoporosis in postmenopausal women and men at increased fracture risk. The objectives were to describe the characteristics of patients with osteoporosis initiating denosumab in Polish clinical practice and their clinical management during the first 12 months of denosumab treatment.
Material and methods: This prospective, observational study enrolled denosumab-naïve women and men in Poland with osteoporosis, who had received at least one denosumab injection in the 8 weeks prior to enrolment. Patients were enrolled from specialist osteoporosis treatment centres, and orthopaedic, rheumatological, and family doctor centres. Outcomes included patient characteristics, denosumab treatment patterns, bone mineral density (BMD), and fracture; all analyses were descriptive.
Results: The study enrolled 463 patients; most (96%) were women, aged ≥ 65 years (84%), with prior fractures (88%). Approximately two-thirds of the women had received prior osteoporosis therapy, with the main reasons for discontinuation being adverse events (75%) and lack of effect (73%). Across all patients, the most common reasons for prescribing denosumab were low bone mineral density (BMD/T-score) (93%) and history of osteoporotic fracture (78%). Mean BMD at denosumab initiation ranged from T-score –3.00 (lumbar spine) to T-score –2.6 (total hip), and BMD increased by 2.8–6.2% at month 12. Most patients completed follow-up (86%) and were due to receive a third denosumab injection (81%).
Conclusion: The article presents detailed sociodemographic and disease-related characteristics of patients who routinely implemented denosumab therapy. Most of them continued denosumab for at least 12 months, with increased BMD T-scores.
Abstract
Introduction: The receptor activator for nuclear factor k B ligand (RANKL) inhibitor denosumab is approved for the treatment of osteoporosis in postmenopausal women and men at increased fracture risk. The objectives were to describe the characteristics of patients with osteoporosis initiating denosumab in Polish clinical practice and their clinical management during the first 12 months of denosumab treatment.
Material and methods: This prospective, observational study enrolled denosumab-naïve women and men in Poland with osteoporosis, who had received at least one denosumab injection in the 8 weeks prior to enrolment. Patients were enrolled from specialist osteoporosis treatment centres, and orthopaedic, rheumatological, and family doctor centres. Outcomes included patient characteristics, denosumab treatment patterns, bone mineral density (BMD), and fracture; all analyses were descriptive.
Results: The study enrolled 463 patients; most (96%) were women, aged ≥ 65 years (84%), with prior fractures (88%). Approximately two-thirds of the women had received prior osteoporosis therapy, with the main reasons for discontinuation being adverse events (75%) and lack of effect (73%). Across all patients, the most common reasons for prescribing denosumab were low bone mineral density (BMD/T-score) (93%) and history of osteoporotic fracture (78%). Mean BMD at denosumab initiation ranged from T-score –3.00 (lumbar spine) to T-score –2.6 (total hip), and BMD increased by 2.8–6.2% at month 12. Most patients completed follow-up (86%) and were due to receive a third denosumab injection (81%).
Conclusion: The article presents detailed sociodemographic and disease-related characteristics of patients who routinely implemented denosumab therapy. Most of them continued denosumab for at least 12 months, with increased BMD T-scores.
Keywords
denosumab; osteoporosis; postmenopausal osteoporosis; therapy
Title
Osteoporosis treatment with denosumab in routine clinical practice in Poland
Journal
Issue
Article type
Original paper
Pages
243-253
Published online
2023-06-21
Page views
1635
Article views/downloads
565
DOI
Pubmed
Bibliographic record
Endokrynol Pol 2023;74(3):243-253.
Keywords
denosumab
osteoporosis
postmenopausal osteoporosis
therapy
Authors
Ewa Marcinowska-Suchowierska
Tomasz Blicharski
Ewa Wielosz
Maria Rell-Bakalarska
Krzysztof Duma
Katarzyna Paradowska-Kowal
Ewa Sewerynek
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