Real-world Effectiveness of Romosozumab: Bone Density Gains and Safety Outcomes in a Turkish Severe Osteoporosis Cohort – A Single-center Retrospective Cross-sectional Study Romosozumabın Gerçek Yaşam Etkinliği: Türk Şiddetli Osteoporoz Kohortunda Kemik Yoğunluğu Artışı ve Güvenlilik Sonuçları – Tek Merkezli Retrospektif Kesitsel Bir Çalışma
Turk Osteoporoz Dergisi, cilt.32, sa.1, ss.30-38, 2026 (Scopus, TRDizin)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 32 Sayı: 1
- Basım Tarihi: 2026
- Doi Numarası: 10.4274/tod.galenos.2025.98975
- Dergi Adı: Turk Osteoporoz Dergisi
- Derginin Tarandığı İndeksler: Scopus, CINAHL, EMBASE, TR DİZİN (ULAKBİM), Academic Search Ultimate (EBSCO), Biomedical Reference Collection: Corporate Edition (EBSCO), Health Research Premium Collection (ProQuest)
- Sayfa Sayıları: ss.30-38
- Anahtar Kelimeler: Osteoporosis, romosozumab, bone density, retrospective studies
- Açık Arşiv Koleksiyonu: AVESİS Açık Erişim Koleksiyonu
- Sağlık Bilimleri Üniversitesi Adresli: Evet
Özet
Objective: To determine, in a real-world setting, the 12-month effects of romosozumab on bone mineral density (BMD) and T-scores in Turkish patients with severe osteoporosis. Materials and Methods: This single-center, retrospective real-life cohort included 124 consecutive patients followed between October 2023 and March 2025. Twenty-nine patients met predefined exclusion criteria and were removed; the final analysis comprised 95 patients who had received monthly subcutaneous romosozumab 210 mg for 12 months. BMD of the lumbar spine (L1-L4 and L2–L4), femoral neck, and total hip was assessed by dual-energy X-ray absorptiometry at baseline, month 6, and month 12. Within-patient changes were analyzed using the Wilcoxon signed-rank test. Comparisons according to sex and prior anti-osteoporotic therapy (treatment-naïve vs. previously treated) were performed using the Mann-Whitney U test. Results: Of the cohort, 89.5% were women and the median age was 73 years. Median baseline BMD at L1-L4 was 0.671 g/cm2 (T-score -3.50) and increased to 0.762 g/cm2 at 12 months (+13.6%, p<0.001). At L2–L4, BMD increased to 0.750 g/cm2 (+14.9%, p<0.001). Femoral neck BMD rose to 0.548 g/cm2 (+4.9%, p<0.001), and total hip BMD to 0.668 g/cm2 (+3.7%, p<0.001). Corresponding median T-score gains were +0.47, +0.52, +0.11, and +0.08 SD units, respectively. The magnitude of BMD and T-score improvement did not differ by sex (women n=85, men n=10) or by prior treatment status (treatment-naïve n=24, previously treated n=71) (all p>0.05). Treatment was discontinued in one patient because of palpitations judged unrelated to the drug; nine patients (9.5%) reported mild adverse events such as nasopharyngitis, injection-site reactions, and low back pain. Conclusion: In this real-world Turkish cohort with severe osteoporosis, 12 months of romosozumab was associated with rapid and clinically meaningful increases in spinal and hip BMD, maintained through 1-year and unaffected by sex or previous pharmacotherapy. The observed safety profile supports the use of romosozumab in high-risk patients.