Examining Romosozumab Adherence and Side Effects in Osteoporotic Patients After Surgical Fracture Fixation: A Comparative, Descriptive, and Hypothesis-Generating Study with Non-Fractured Controls.

Abstract

Objectives: The study aims to evaluate adherence to Romosozumab treatment in osteoporotic patients after surgical fracture fixation and compare side effects with non-fractured controls on the same therapy.

Methods: This retrospective case-control study was conducted at the Orthopaedic Department of Policlinico Universitario di Roma "Tor Vergata", following the principles of the Declaration of Helsinki. It included postmenopausal women aged over 60, with the case group receiving Romosozumab after fracture fixation, and the control group consisting of women on Romosozumab therapy without fracture fixation. Exclusion criteria included psychiatric conditions, contraindications to Romosozumab, high-energy trauma, or other bone metabolism disorders. Data on fractures, surgeries, FRAX (Fracture Risk Assessment Tool) scores, BMD (Bone Mineral Densit) values, and follow-up details were collected. Side effects, including nasopharyngitis and severe events like hypocalcemia, stroke, and myocardial infarction, were recorded. Adherence was assessed via pharmacy records and patient interviews during routine clinical follow-up visits. Statistical analysis was performed using descriptive statistics, t-tests, and chi-square tests.

Results: The study included 25 patients, with 12 in the surgical group and 13 in the conservative treatment group. The surgical group had a mean age of 67.3 years and a follow-up of 374 days, while the conservative group had a mean age of 76.4 years and a follow-up of 287 days. The surgical group underwent various fracture treatments, including femoral, humeral, and distal radius fractures, while the conservative group was treated with immobilization. There were no significant differences in FRAX scores or BMD values between the two groups. Vitamin D levels increased significantly in both groups after supplementation, but parathyroid hormone levels showed no difference. No new fractures occurred, and surgical patients had no delayed union or nonunion, though two had superficial wound infections.

Conclusions: Both groups adhered well to Romosozumab therapy, with no severe side effects; minor side effects included myalgia in the surgical group and shoulder arthralgia in the conservative group. Romosozumab is well-tolerated and adherent in osteoporotic patients after osteosynthesis surgery, with adverse events similar to non-fractured individuals. While the study design is appropriate, multicenter trials would improve the sample size and allow for subgroup analysis based on fracture type and demographics.