Abs0435 Abaloparatide in Osteoporosis: a Descriptive Study From a Spanish Multicenter Cohort
Year: 2025
Type: conference-abstract
Abstract: Background: Abaloparatide (ABL) is a novel synthetic analog of human parathyroid hormone that selectively binds to the RG conformation of the hormone type 1 receptor. Recently, it has been approved in Spain for the treatment of osteoporosis in patients at high risk of fractures [1, 2]. This multicenter cohort evaluates the clinical characteristics, indications for treatment, laboratory findings, and densitometric features of patients who initiated ABL therapy after its commercialization in Spain. Objectives: To describe the clinical features of a cohort of spanish patients with osteoporosis who initiate treatment with ABL, including their associated risk factors, history of fractures, laboratory and densitometric parameters. Methods: A retrospective multicentre descriptive study was conducted on patients treated with ABL in 3 hospitals in eastern Spain. Demographic data, history of fractures, risk factors (smoking, alcohol consumption, physical activity and comorbidities), previous treatments for osteoporosis, laboratory markers of bone metabolism, and densitometry T-scores (including lumbar spine, femoral neck and total hip) were included. Reasons for ABL prescription were classified as first line, second line (lack of efficacy or need for greater efficacy) and due to adverse effects of previous therapies. Discontinuation and adverse effects were also registered. A descriptive study of the variables included in the study was carried out. Quantitative variables were presented as means and standard deviations (SD) or medians and interquartile ranges (IQR) depending on whether they distribution was normal. Qualitative variables were expressed as absolute frequency and percentage. Statistical analysis was performed with SPSS version 21.0. Results: A total of 58 patients were included in the study, with a median age of 67.5 years [IQR 61.25–74]. Treatments were initiated between May 2024 and January 2025. 79.3% had at least one previous fracture, with vertebral fractures being the most frequent (60.71%), followed by wrist (10.71%) and hip (8.93%). The mean number of fractures per patient was 1.8 ± 1.77 SD. The risk factors and comorbidities are shown in Table 1. Previous treatments are shown in Table 2. Patients had a median CTX level of 0.479 ng/mL [IQR 0.255-0.63]. No patient presented with hypercalcemia or hyperparathyroidism. Additionally, 10 patients (17.24%) presented with 25(OH) vitamin D concentration below 30 ng/ml. Densitometry showed a mean T-score in the lumbar spine of -2.90 ± 1.24 SD, in the femoral neck of -2.64 ± 1.01 SD, and in the total hip of -2.70 ± 1.21 SD. Regarding ABL prescription, 32 patients (55.17%) received the treatment as a first-line therapy while 22 patients (37.93%) as a second line therapy (due to lack of efficacy of previous treatments or the need for greater efficacy). Additionally, 3 patients (5.17%) initiated ABL due to adverse effects of previous anabolic agents, and 1 patient for safety reasons related to dental pathology. During follow-up there were 5 discontinuations; 4 were due to non-severe adverse effects (1 headache, 1 stomach ache, 1 dizziness and 1 tachycardia) and 1 was due to the patient's own decision. No fractures were recorded during the follow-up period. Conclusion: This multicenter cohort study highlights the clinical characteristics of patients treated with ABL in real-world settings, characterized by a predominance of spinal osteoporosis, as evidenced by both densitometric findings and fracture prevalence. The data emphasize the use of ABL as both first-line and second-line therapy, often due to lack of efficacy or adverse effects of previous treatments, primarily bisphosphonates but also other anabolic agents. No fractures were recorded during follow-up, and discontinuations were mostly related to mild adverse effects. These findings support the role of ABL in managing patients with high fracture risk and previous treatment challenges. Further studies are needed to assess its long-term efficacy and safety in a real-world population. REFERENCES: NIL . Table 1Risk factors and comorbidities.Woman, n (%)58/58 (100)Active smokers, n (%)16/58 (27.59)Alcohol consumption, n (%)2/58 (3.45)Non regular physical activity, n (%)41/58 (70.69)Diabetes mellitus, n (%)4/58 (6.9)Dyslipidemia, n (%)6/58 (10.34)High blood pressure, n (%)2/58 (3.45)Chronic kidney disease, n (%)5/58 (8.62)Hypothyroidism, n (%)5/58 (8.62)Cardiovascular disease, n (%)6/58 (10.34)Inflammatory autoimmune disease, n (%)10/58 (17.24)Solid organ transplant, n (%)2/58 (3.45) Table 2Previous treatments.DrugNumber of patients (n, %)Median time of use (months)Oral bisphosphonatesTotal18/58 (31)13 [IQR 6–48]Alendronate12/18 (66.7)Risedronate4/18 (22.3)Ibandronate2/18 (11.1)Zoledronate4/58 (6.9)21 [IQR 15-36]Denosumab6/58 (19.34)30 [IQR 19.5-36]Teriparatide6/58 (10.34)11.5 [IQR 5.25-17.75]Romosozumab2/58 (3.45)8 [IQR 6-10] Acknowledgements: We would like to express our gratitude to the rheumatologists from the participating hospital services for their valuable contribution to this study. Disclosure of Interests: None declared . © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.
Source: Annals of the Rheumatic Diseases
Language: English
Subfield: Orthopedics and Sports Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,870
OpenAlex ID: W4411427758