MON-822 - Real-World Effectiveness, Safety, and Compliance With Romosozumab in Osteoporosis: A Retrospective Cohort Study From a Tertiary Care Center

The Efficacy of Anti-sclerostin Monoclonal Anti-body: Real World Data

Background:
Romosozumab is FDA approved for post-menopausal. However, due to limitation of anabolic agent in osteoporosis, It sometimes used as off-label for other high risk population. We aimed to look for the efficacy of Romosozumab in OP with different etiology, and its safety in CVD patient as well as malignancy. Nonetheless, its efficacy in non-compliant patient.

Method:
Retrospective chart review for all patient used Romosuzmab in our center between Jan 2023 till Dec 2025. Study conducted in King Abdulaziz Medical city in Jeddah, KSA. We included all patient prescribed Romosozumab in this period. Patient were recruited and demographics data were collected, etiology for their OP, previous use of steroid, previous use of OP medications, labs and BMD at baseline and after treatment, compliance and adverse events.
Result
Total of 154 patients were prescribed for romosozumab, Average age was 69 (+/-9) years. 138 (97%) were female while 4 (2.8%) were male. Post-menopausal OP constituted 110 (79%) of all patients, steroid induced OP 19 (14%), 11(7.8%) were due other etiologies. 9 (6.4%) and 31 (22%) had history of (CVD and/or stroke) and Hx of Malignancy respectively. 99 (71%) were compliant, while 41 (29%) were not compliant to treatment.
Analysis done on 71 patients completed the treatment and post-treatment work-up. BMD in DEXA scan spine showed improvement from 0.817 mg/cm2 to 0.900 mg/cm2 (P-value < 0.05) (T-score from -2.9 to -2.2, p-value < 0.05), at Rt femoral neck from 0.706 mg/cm2 to 0.729 mg/cm2 (P-value < 0.05) (T-score -2.3 to -2.0, P-value < 0.05), and at Lt femoral neck from 0.687 mg/cm2 to 0.703 mg/cm2 (P-value 0.124) (T-score -2.5 to -2.2).
No efficacy demonstrated in non-compliant patient at all 3 sites. 8 (5.6%) patients had passed away, and MACE complications reported in 4 (2.8%) patients. Only 1 patient had relapse of the malignancy, which was small lymphocytic lymphoma.

Conclusion:
In this real-world cohort from a tertiary care center in Saudi Arabia, Romosozumab was associated with significant improvement in lumbar spine and right femoral neck BMD among patients who completed treatment, supporting its effectiveness in routine clinical practice across a predominantly high-risk osteoporosis population. No meaningful benefit was observed in non-compliant patients, highlighting the importance of treatment adherence. The overall safety findings were acceptable, with limited reported MACE events and no clear signal of increased malignancy recurrence, although larger studies with longer follow-up are needed to better define safety in patients with cardiovascular disease and prior malignancy.

*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*