Effects of romosozumab on bone strength around a pedicle screw as evaluated by biomechanical computed tomography-based virtual stress tests in postmenopausal women
Abstract
BACKGROUND CONTEXT: Osteoporosis is a significant risk factor for complications after spinal fusion surgery. Romosozumab, a sclerostin inhibitor, is approved for treating osteoporosis in postmenopausal women at high fracture risk.
PURPOSE: Here we investigated the theoretical effects of romosozumab on changes in vertebral strength around virtually-implanted pedicle screws, using biomechanical computed tomography (BCT).
STUDY DESIGN/SETTING: This retrospective secondary analysis utilized CT scans from 2 randomized clinical trials of osteoporosis drug treatments in postmenopausal women: a phase 2 trial (12-month romosozumab vs placebo vs teriparatide) in women with low bone mineral density (BMD) and a phase 3 trial (12-month romosozumab followed by 12-month alendronate vs 24-month alendronate alone) in women with osteoporosis.
PATIENT SAMPLE: Subsets of 82 patients from the phase 2 trial who received subcutaneous romosozumab 210 mg/mo, placebo, or subcutaneous teriparatide 20 μg/d and 90 patients from the phase 3 trial were included in respective imaging substudies. Patients from the substudies in the present analysis had to have baseline and ≥1 postbaseline BCT measurement at Month 12 in the phase 2 trial, and at Months 6, 12, and 24 in the phase 3 trial.
OUTCOME MEASURES: The primary endpoints were percent changes (follow-up vs baseline) in shear bone strength and volume of failed tissue compared between treatments; the secondary endpoint was percent change from baseline in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 90 participants or records.
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