CO:07:1 | Assessing bone fragility in systemic sclerosis: results of the Sclerobone multicentric study
Abstract
Background: Considering the limited and conflicting data regarding prevalence and risk factors of osteoporosis (OP) in systemic sclerosis (SSc), we aimed at evaluating a large population of patients at several Italian institutions. Enrollment started in October 2024 and will end in October 2025.
Materials and Methods: We are investigating the presence of OP in randomly selected subjects fulfilling the 2013 ACR/EULAR SSc classification criteria using a partially retrospective design. Exclusion criteria include ongoing pregnancy, cancer, metabolic bone diseases other than OP, and therapies interfering with bone health; exceptions are chronic kidney disease, anti-osteoporotic drugs, glucocorticoids (GC), and proton pump inhibitors. OP was defined as history of fragility fractures (FX) and/or of bone mineral density (BMD) values with T-scores < -2.5 or Z-scores < -2.0. BMD is evaluated using DXA scans within 12 months before enrollment or performed at enrollment. Demographic and anthropometric data, menopausal status, dietary calcium intake, Charlson Comorbidity Index (CCI), and concurrent medications are assessed. Sarcopenia, when detected with the SARC-F+EBM questionnaire, is evaluated with functional tests such as hand grip strength, chair stand test, and gait speed. A characterization of SSc is performed, including age at diagnosis, disease duration, and organ involvement. The cumulative SSc-related damage is expressed with the Scleroderma Clinical Trials Consortium Damage Index (SCTC-DI). We provide the results of the pre-planned interim analysis performed in April 2025; the final analysis is planned in October 2025.
Results: The interim analysis focused on 315 patients, with a mean age at enrollment of 63.2±11.3 years. They were diagnosed with SSc at a mean age of 51.2±12.4 years and had been affected for a median time of 10 years (interquartile range - IQR 12). Females made up the majority (n = 292; 92.7%) of the cohort, with 266 (91.1%) having been postmenopausal for a mean time of 17.3±10.1 years. The mean BMI was 24.3±4.4 kg/m², and 16.8% of patients were sarcopenic. Dietary calcium intake was insufficient (<700 mg) in 70.4% of cases, and optimal (>1000 mg) only in 3.9%. Approximately 30% of patients were taking GCs. The mean CCI score was 3.7±1.6, suggesting a 10-year mortality risk of approximately 40%. The median SCTC-DI score was 3 (IQR 3). Our main finding was that OP affected 136 (43.2%) subjects: 84 (61.8%) had reduced BMD values only, and 52 (38.2%) had a history of FX.
Conclusions: Our interim analysis showed that 43.2% of patients were affected by OP, suggesting a potentially high burden in SSc. To identify any predictive factors of OP in SSc, the final analysis will include correlations with SSc organ involvement, biochemical markers, densitometric values, sarcopenia, body composition parameters, and FX risk calculations with the DeFRA algorithm.
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